<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03761368</url>
  </required_header>
  <id_info>
    <org_study_id>RNN/219/13/KE</org_study_id>
    <nct_id>NCT03761368</nct_id>
  </id_info>
  <brief_title>Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective PCI</brief_title>
  <official_title>Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention - Randomised Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Lodz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Lodz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, randomized, sham-controlled clinical study was conducted to assess whether RIPC&#xD;
      reduces the incidence of CI-AKI measured standard way of using SCr concentration but also&#xD;
      with the use of serum NGAL as a new potential biomarker of kidney injury. Furthermore, the&#xD;
      aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective&#xD;
      coronary angiography (CA) followed by percutaneous coronary intervention (PCI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nowadays CI-AKI is defined according to serum creatinine concentration (SCr) as any of the&#xD;
      following: (1) an absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or (2) a relative increase of&#xD;
      25% in serum creatinine compared to baseline within 48 to 72 hours after contrast&#xD;
      administration. In the last decades, several novel biomarkers of AKI have been studied&#xD;
      including neutrophil gelatinase-associated lipocalin (NGAL). Furthermore, remote ischemic&#xD;
      preconditioning (RIPC) turned out to be one of the most promising and intriguing&#xD;
      non-pharmacological strategy. This simple procedure consisting of brief, non-lethal episodes&#xD;
      of ischemia and reperfusion applied in one tissue or organ protects remote tissues or organs&#xD;
      from subsequent injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2015</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>After admission to the Department, patients were randomly assigned in 1:1 ratio to either control group or RIPC - group by means of a computerized randomization table.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Blinded investigator, not involved in either CA or randomization procedure, performed assignment intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Contrast Induced-Acute Kidney Injury</measure>
    <time_frame>48 to 72 hours after contrast exposure</time_frame>
    <description>absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Need of Renal Replacement Therapy</measure>
    <time_frame>up to 7 days after contrast exposure</time_frame>
    <description>qualification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Presented Cardiogenic Shock</measure>
    <time_frame>up to 7 days after contrast exposure</time_frame>
    <description>sustained hypotension (systolic blood pressure &lt; 90 mm Hg for ≥30 min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death of Any Cause</measure>
    <time_frame>up to one month after contrast exposure</time_frame>
    <description>Number of patients who died.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Remote Ischemic Preconditioning</condition>
  <condition>Contrast Induced - Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>RIPC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The RIPC group underwent Remote Ischemic Preconditioning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients from control group had sham Remote Ischemic Preconditioning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Remote Ischemic Preconditioning</intervention_name>
    <description>four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff</description>
    <arm_group_label>RIPC group</arm_group_label>
    <other_name>RIPC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham Remote Ischemic Preconditioning</intervention_name>
    <description>deflated cuff placed on the left arm for 40 min</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Sham RIPC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged over 18 years&#xD;
&#xD;
          -  patients with stable angina pectoris&#xD;
&#xD;
          -  patients admitted to Intensive Cardiac Therapy Clinic Medical University of Lodz with&#xD;
             intention of elective CA with follow-up PCI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of severe injuries up to 2 months before intervention&#xD;
&#xD;
          -  history of surgeries up to 2 months before intervention&#xD;
&#xD;
          -  history of cancer,&#xD;
&#xD;
          -  acute inflammation during hospitalization&#xD;
&#xD;
          -  chronic autoimmunologic diseases&#xD;
&#xD;
          -  patients needing hemodialysis&#xD;
&#xD;
          -  chronic kidney disease in stage 4 or 5 (eGFR&lt;30 ml/min/1,73m2)&#xD;
&#xD;
          -  peripheral vascular disease affecting upper limbs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marzenna Zielinska, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University of Lodz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Intensive Cardiac Therapy Clinic</name>
      <address>
        <city>Lodz</city>
        <zip>92-213</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <results_first_submitted>June 12, 2020</results_first_submitted>
  <results_first_submitted_qc>October 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 30, 2020</results_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Lodz</investigator_affiliation>
    <investigator_full_name>Karolina Stokfisz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>remote ischemic preconditioning</keyword>
  <keyword>contrast induced-acute kidney injury</keyword>
  <keyword>neutrophil gelatinase-associated lipocalin</keyword>
  <keyword>percutaneous coronary intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data sets used and/or analyzed during the current study are available from the corresponding author on reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>3 years after the end of the study</ipd_time_frame>
    <ipd_access_criteria>on reasonable request</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03761368/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03761368/Prot_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients aged over 18 years presented with stable angina pectoris, admitted to Intensive Cardiac Therapy Clinic Medical University of Lodz and scheduled for elective CA with follow-up PCI.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>RIPC Group</title>
          <description>The RIPC group underwent Remote Ischemic Preconditioning.&#xD;
Remote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Patients from control group had sham Remote Ischemic Preconditioning.&#xD;
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>RIPC Group</title>
          <description>The RIPC group underwent Remote Ischemic Preconditioning.&#xD;
Remote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left arm cuff</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Patients from control group had sham Remote Ischemic Preconditioning.&#xD;
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="101"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Contrast Medium Intake</title>
          <units>ml</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100" lower_limit="80" upper_limit="140"/>
                    <measurement group_id="B2" value="110" lower_limit="90" upper_limit="140"/>
                    <measurement group_id="B3" value="110" lower_limit="80" upper_limit="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum creatinine on admission</title>
          <units>µmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87" lower_limit="81" upper_limit="96"/>
                    <measurement group_id="B2" value="88" lower_limit="82" upper_limit="101"/>
                    <measurement group_id="B3" value="88" lower_limit="81" upper_limit="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NGAL on admission</title>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.3" lower_limit="55.8" upper_limit="86.8"/>
                    <measurement group_id="B2" value="80.6" lower_limit="55.8" upper_limit="101.2"/>
                    <measurement group_id="B3" value="74.4" lower_limit="55.8" upper_limit="102.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Contrast Induced-Acute Kidney Injury</title>
        <description>absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline</description>
        <time_frame>48 to 72 hours after contrast exposure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RIPC Group</title>
            <description>The RIPC group underwent Remote Ischemic Preconditioning.&#xD;
Remote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Patients from control group had sham Remote Ischemic Preconditioning.&#xD;
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Contrast Induced-Acute Kidney Injury</title>
          <description>absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Need of Renal Replacement Therapy</title>
        <description>qualification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management)</description>
        <time_frame>up to 7 days after contrast exposure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RIPC Group</title>
            <description>The RIPC group underwent Remote Ischemic Preconditioning.&#xD;
Remote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Patients from control group had sham Remote Ischemic Preconditioning.&#xD;
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Need of Renal Replacement Therapy</title>
          <description>qualification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Presented Cardiogenic Shock</title>
        <description>sustained hypotension (systolic blood pressure &lt; 90 mm Hg for ≥30 min)</description>
        <time_frame>up to 7 days after contrast exposure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RIPC Group</title>
            <description>The RIPC group underwent Remote Ischemic Preconditioning.&#xD;
Remote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Patients from control group had sham Remote Ischemic Preconditioning.&#xD;
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Presented Cardiogenic Shock</title>
          <description>sustained hypotension (systolic blood pressure &lt; 90 mm Hg for ≥30 min)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Death of Any Cause</title>
        <description>Number of patients who died.</description>
        <time_frame>up to one month after contrast exposure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RIPC Group</title>
            <description>The RIPC group underwent Remote Ischemic Preconditioning.&#xD;
Remote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Patients from control group had sham Remote Ischemic Preconditioning.&#xD;
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min</description>
          </group>
        </group_list>
        <measure>
          <title>Death of Any Cause</title>
          <description>Number of patients who died.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to one month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>RIPC Group</title>
          <description>The RIPC group underwent Remote Ischemic Preconditioning.&#xD;
Remote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper-arm cuff</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Patients from control group had sham Remote Ischemic Preconditioning.&#xD;
Sham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>skin petechiae</sub_title>
                <description>petechiae on the skin of preconditioned arm distally to upper - arm cuff placement</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Single-center trial.&#xD;
Relatively small sample size.&#xD;
We were unable to observe sufficient number of events, such as CI-AKI, mortality, need for dialysis as an endpoint.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Karolina Stokfisz</name_or_title>
      <organization>Medical University of Łódź</organization>
      <phone>+48422014260</phone>
      <email>stokfisz.karolina@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03761368
org study id: RNN/219/13/KE
nct id: NCT03761368
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, randomized, sham-controlled clinical study was conducted to assess whether RIPC
      reduces the incidence of CI-AKI measured standard way of using SCr concentration but also
      with the use of serum NGAL as a new potential biomarker of kidney injury. Furthermore, the
      aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective
      coronary angiography (CA) followed by percutaneous coronary intervention (PCI).
Nowadays CI-AKI is defined according to serum creatinine concentration (SCr) as any of the
      following: (1) an absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or (2) a relative increase of
      25% in serum creatinine compared to baseline within 48 to 72 hours after contrast
      administration. In the last decades, several novel biomarkers of AKI have been studied
      including neutrophil gelatinase-associated lipocalin (NGAL). Furthermore, remote ischemic
      preconditioning (RIPC) turned out to be one of the most promising and intriguing
      non-pharmacological strategy. This simple procedure consisting of brief, non-lethal episodes
      of ischemia and reperfusion applied in one tissue or organ protects remote tissues or organs
      from subsequent injury.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: After admission to the Department, patients were randomly assigned in 1:1 ratio to either control group or RIPC - group by means of a computerized randomization table.
primary purpose: Prevention
masking: Single (Investigator)
masking description: Blinded investigator, not involved in either CA or randomization procedure, performed assignment intervention.
measure: Number of Participants With Contrast Induced-Acute Kidney Injury
time frame: 48 to 72 hours after contrast exposure
description: absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline
measure: Number of Participants With Need of Renal Replacement Therapy
time frame: up to 7 days after contrast exposure
description: qualification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management)
measure: Number of Participants Who Presented Cardiogenic Shock
time frame: up to 7 days after contrast exposure
description: sustained hypotension (systolic blood pressure < 90 mm Hg for ≥30 min)
measure: Death of Any Cause
time frame: up to one month after contrast exposure
description: Number of patients who died.
arm group label: RIPC group
arm group type: Experimental
description: The RIPC group underwent Remote Ischemic Preconditioning.
arm group label: Control group
arm group type: Sham Comparator
description: Patients from control group had sham Remote Ischemic Preconditioning.
intervention type: Procedure
intervention name: Remote Ischemic Preconditioning
description: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff
arm group label: RIPC group
other name: RIPC
intervention type: Procedure
intervention name: Sham Remote Ischemic Preconditioning
description: deflated cuff placed on the left arm for 40 min
arm group label: Control group
other name: Sham RIPC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marzenna Zielinska, MD PhD
role: Study Chair
affiliation: Medical University of Lodz
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Lodz
investigator full name: Karolina Stokfisz
investigator title: Principal Investigator
mesh term: Acute Kidney Injury
mesh term: Ischemia
mesh term: Wounds and Injuries
sharing ipd: Yes
ipd description: The data sets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 3 years after the end of the study
ipd access criteria: on reasonable request
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Single-center trial.
Relatively small sample size.
We were unable to observe sufficient number of events, such as CI-AKI, mortality, need for dialysis as an endpoint.
point of contact: 