<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/NCT03273751</url>
  </required_header>
  <id_info>
    <org_study_id>1707-087-870</org_study_id>
    <nct_id>NCT03273751</nct_id>
  </id_info>
  <brief_title>The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy</brief_title>
  <official_title>The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy : A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      This study is intended to evaluate the renal protective effect of Remote Ischemic&#xD;
      Preconditioning (RIPC) in patients undergoing partial nephrectomy. Half of the enrolled&#xD;
      subjects will receive 4 cycles of brief ischemia on the upper arm after anesthesia induction&#xD;
      and prior to the surgery, while the other half will not receive this treatment as a control&#xD;
      group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Remote Ischemic Preconditioning (RIPC) is the concept of mitigating ischemia-reperfusion&#xD;
      injury to target organs by a brief episode of ischemia-reperfusion of the limb. The&#xD;
      protective effect of RIPC on major organs has been demonstrated in an animal study, but its&#xD;
      clinical efficacy has not yet been established.&#xD;
&#xD;
      The kidney is a typical organ vulnerable to ischemic injury, and the renal protective effect&#xD;
      of RIPC can be expected. There have been many reports of renal protective effects of RIPC in&#xD;
      cardiac and vascular surgery. On the other hand, few studies have investigated the effect of&#xD;
      RIPC during partial nephrectomy in which ischemia-reperfusion injury can occur during the&#xD;
      surgery.&#xD;
&#xD;
      In this study, the investigators will evaluate the effect of RIPC in patients undergoing&#xD;
      partial nephrectomy to prevent renal impairment and improve the prognosis after the surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">August 28, 2018</completion_date>
  <primary_completion_date type="Actual">August 28, 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>A prospective, randomized, parallel group, controlled study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participants, care providers, investigators and outcome assessors will be blinded to group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Serum creatinine level</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>Postoperative serum creatinine levels as an index of kidney damage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of acute kidney injury (AKI)</measure>
    <time_frame>Within 7 days after surgery</time_frame>
    <description>The incidence of AKI according to the serum creatinine diagnostic criteria of Kidney Disease Improving Global outcomes (KDIGO) Clinical Practice Guideline for AKI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum creatinine level</measure>
    <time_frame>1 hour after surgery</time_frame>
    <description>Postoperative serum creatinine levels as an index of kidney damage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum creatinine level</measure>
    <time_frame>Postoperative day 3</time_frame>
    <description>Postoperative serum creatinine levels as an index of kidney damage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum creatinine level</measure>
    <time_frame>2 weeks after surgery</time_frame>
    <description>Postoperative serum creatinine levels as an index of kidney damage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>estimated glomerular filtration rate (eGFR)</measure>
    <time_frame>1 hour after surgery</time_frame>
    <description>eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>estimated glomerular filtration rate (eGFR)</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>estimated glomerular filtration rate (eGFR)</measure>
    <time_frame>Postoperative day 3</time_frame>
    <description>eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>estimated glomerular filtration rate (eGFR)</measure>
    <time_frame>2 weeks after surgery</time_frame>
    <description>eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side</measure>
    <time_frame>5 min after the induction of anesthesia (baseline)</time_frame>
    <description>Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side</measure>
    <time_frame>30 minutes after induction of anesthesia</time_frame>
    <description>Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side</measure>
    <time_frame>60 minutes after induction of anesthesia</time_frame>
    <description>Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side</measure>
    <time_frame>90 minutes after induction of anesthesia</time_frame>
    <description>Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine creatinine level</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>Urine creatinine level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine creatinine level</measure>
    <time_frame>2 weeks after surgery</time_frame>
    <description>Urine creatinine level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine microalbumin</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>Urine microalbumin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine microalbumin</measure>
    <time_frame>2 weeks after surgery</time_frame>
    <description>Urine microalbumin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine beta-2 microglobulin</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>Urine beta-2 microglobulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine beta-2 microglobulin</measure>
    <time_frame>2 weeks after surgery</time_frame>
    <description>Urine beta-2 microglobulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine N-acetyl-beta-D-glucosaminidase</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>Urine N-acetyl-beta-D-glucosaminidase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine N-acetyl-beta-D-glucosaminidase</measure>
    <time_frame>2 weeks after surgery</time_frame>
    <description>Urine N-acetyl-beta-D-glucosaminidase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glomerular filtration rate measured by scintigraphy</measure>
    <time_frame>preoperative baseline</time_frame>
    <description>Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glomerular filtration rate measured by scintigraphy</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glomerular filtration rate measured by scintigraphy</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Renal Neoplasm</condition>
  <condition>Renal Injury</condition>
  <arm_group>
    <arm_group_label>Remote Ischemic Preconditioning (RIPC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four cycles of upper arm ischemia/reperfusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Placement of a blood pressure cuff around upper arm without inflation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Remote Ischemic Preconditioning</intervention_name>
    <description>After induction of anesthesia, RIPC consisted of four 5-min cycles of limb ischemia induced by a blood pressure cuff placed on the upper arm and inflated to 250 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated.</description>
    <arm_group_label>Remote Ischemic Preconditioning (RIPC)</arm_group_label>
    <other_name>RIPC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham control</intervention_name>
    <description>After induction of anesthesia, sham control consisted of the placement of a blood pressure cuff on the upper arm with no inflation during the surgery.</description>
    <arm_group_label>Sham control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients scheduled to undergo open, laparoscopic, or robot-assisted laparoscopic&#xD;
             partial nephrectomy&#xD;
&#xD;
          -  Normal contralateral renal function was defined as split renal function of &gt;40% as&#xD;
             determined by preoperative Tc-99m DiethyleneTriamine Pentaacetic Acid (DTPA) kidney&#xD;
             scan&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Peripheral vascular disease involving upper extremities or lower extremities&#xD;
&#xD;
          -  Severe cardiopulmonary diseases (valvular or ischemic heart disease, heart failure,&#xD;
             chronic obstructive pulmonary disease)&#xD;
&#xD;
          -  Hepatic failure, renal failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Won Ho Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Huang J, Chen Y, Dong B, Kong W, Zhang J, Xue W, Liu D, Huang Y. Effect of remote ischaemic preconditioning on renal protection in patients undergoing laparoscopic partial nephrectomy: a 'blinded' randomised controlled trial. BJU Int. 2013 Jul;112(1):74-80. doi: 10.1111/bju.12004. Epub 2013 Mar 4.</citation>
    <PMID>23452148</PMID>
  </reference>
  <reference>
    <citation>Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, Wolf B, Goebel U, Schwer CI, Rosenberger P, Haeberle H, Gorlich D, Kellum JA, Meersch M; RenalRIPC Investigators. Effect of remote ischemic preconditioning on kidney injury among high-risk patients undergoing cardiac surgery: a randomized clinical trial. JAMA. 2015 Jun 2;313(21):2133-41. doi: 10.1001/jama.2015.4189.</citation>
    <PMID>26024502</PMID>
  </reference>
  <reference>
    <citation>Zhang L, Diao Y, Chen G, Tanaka A, Eastwood GM, Bellomo R. Remote ischemic conditioning for kidney protection: A meta-analysis. J Crit Care. 2016 Jun;33:224-32. doi: 10.1016/j.jcrc.2016.01.026. Epub 2016 Feb 10.</citation>
    <PMID>26936039</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>September 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Won Ho Kim, MD</investigator_full_name>
    <investigator_title>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Remote Ischemic Preconditioning</keyword>
  <keyword>Partial nephrectomy</keyword>
  <keyword>Acute kidney injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03273751
org study id: 1707-087-870
nct id: NCT03273751
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is intended to evaluate the renal protective effect of Remote Ischemic
      Preconditioning (RIPC) in patients undergoing partial nephrectomy. Half of the enrolled
      subjects will receive 4 cycles of brief ischemia on the upper arm after anesthesia induction
      and prior to the surgery, while the other half will not receive this treatment as a control
      group.
Remote Ischemic Preconditioning (RIPC) is the concept of mitigating ischemia-reperfusion
      injury to target organs by a brief episode of ischemia-reperfusion of the limb. The
      protective effect of RIPC on major organs has been demonstrated in an animal study, but its
      clinical efficacy has not yet been established.

      The kidney is a typical organ vulnerable to ischemic injury, and the renal protective effect
      of RIPC can be expected. There have been many reports of renal protective effects of RIPC in
      cardiac and vascular surgery. On the other hand, few studies have investigated the effect of
      RIPC during partial nephrectomy in which ischemia-reperfusion injury can occur during the
      surgery.

      In this study, the investigators will evaluate the effect of RIPC in patients undergoing
      partial nephrectomy to prevent renal impairment and improve the prognosis after the surgery.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A prospective, randomized, parallel group, controlled study
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Participants, care providers, investigators and outcome assessors will be blinded to group allocation.
measure: Serum creatinine level
time frame: Postoperative day 1
description: Postoperative serum creatinine levels as an index of kidney damage
measure: The incidence of acute kidney injury (AKI)
time frame: Within 7 days after surgery
description: The incidence of AKI according to the serum creatinine diagnostic criteria of Kidney Disease Improving Global outcomes (KDIGO) Clinical Practice Guideline for AKI
measure: Serum creatinine level
time frame: 1 hour after surgery
description: Postoperative serum creatinine levels as an index of kidney damage
measure: Serum creatinine level
time frame: Postoperative day 3
description: Postoperative serum creatinine levels as an index of kidney damage
measure: Serum creatinine level
time frame: 2 weeks after surgery
description: Postoperative serum creatinine levels as an index of kidney damage
measure: estimated glomerular filtration rate (eGFR)
time frame: 1 hour after surgery
description: eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).
measure: estimated glomerular filtration rate (eGFR)
time frame: Postoperative day 1
description: eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).
measure: estimated glomerular filtration rate (eGFR)
time frame: Postoperative day 3
description: eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).
measure: estimated glomerular filtration rate (eGFR)
time frame: 2 weeks after surgery
description: eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).
measure: Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side
time frame: 5 min after the induction of anesthesia (baseline)
description: Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.
measure: Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side
time frame: 30 minutes after induction of anesthesia
description: Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.
measure: Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side
time frame: 60 minutes after induction of anesthesia
description: Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.
measure: Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side
time frame: 90 minutes after induction of anesthesia
description: Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.
measure: Urine creatinine level
time frame: Postoperative day 1
description: Urine creatinine level
measure: Urine creatinine level
time frame: 2 weeks after surgery
description: Urine creatinine level
measure: Urine microalbumin
time frame: Postoperative day 1
description: Urine microalbumin
measure: Urine microalbumin
time frame: 2 weeks after surgery
description: Urine microalbumin
measure: Urine beta-2 microglobulin
time frame: Postoperative day 1
description: Urine beta-2 microglobulin
measure: Urine beta-2 microglobulin
time frame: 2 weeks after surgery
description: Urine beta-2 microglobulin
measure: Urine N-acetyl-beta-D-glucosaminidase
time frame: Postoperative day 1
description: Urine N-acetyl-beta-D-glucosaminidase
measure: Urine N-acetyl-beta-D-glucosaminidase
time frame: 2 weeks after surgery
description: Urine N-acetyl-beta-D-glucosaminidase
measure: Glomerular filtration rate measured by scintigraphy
time frame: preoperative baseline
description: Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy
measure: Glomerular filtration rate measured by scintigraphy
time frame: 6 months after surgery
description: Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy
measure: Glomerular filtration rate measured by scintigraphy
time frame: 12 months after surgery
description: Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy
arm group label: Remote Ischemic Preconditioning (RIPC)
arm group type: Experimental
description: Four cycles of upper arm ischemia/reperfusion
arm group label: Sham control
arm group type: Sham Comparator
description: Placement of a blood pressure cuff around upper arm without inflation.
intervention type: Procedure
intervention name: Remote Ischemic Preconditioning
description: After induction of anesthesia, RIPC consisted of four 5-min cycles of limb ischemia induced by a blood pressure cuff placed on the upper arm and inflated to 250 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated.
arm group label: Remote Ischemic Preconditioning (RIPC)
other name: RIPC
intervention type: Procedure
intervention name: Sham control
description: After induction of anesthesia, sham control consisted of the placement of a blood pressure cuff on the upper arm with no inflation during the surgery.
arm group label: Sham control
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Won Ho Kim, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
citation: Huang J, Chen Y, Dong B, Kong W, Zhang J, Xue W, Liu D, Huang Y. Effect of remote ischaemic preconditioning on renal protection in patients undergoing laparoscopic partial nephrectomy: a 'blinded' randomised controlled trial. BJU Int. 2013 Jul;112(1):74-80. doi: 10.1111/bju.12004. Epub 2013 Mar 4.
PMID: 23452148
citation: Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, Wolf B, Goebel U, Schwer CI, Rosenberger P, Haeberle H, Gorlich D, Kellum JA, Meersch M; RenalRIPC Investigators. Effect of remote ischemic preconditioning on kidney injury among high-risk patients undergoing cardiac surgery: a randomized clinical trial. JAMA. 2015 Jun 2;313(21):2133-41. doi: 10.1001/jama.2015.4189.
PMID: 26024502
citation: Zhang L, Diao Y, Chen G, Tanaka A, Eastwood GM, Bellomo R. Remote ischemic conditioning for kidney protection: A meta-analysis. J Crit Care. 2016 Jun;33:224-32. doi: 10.1016/j.jcrc.2016.01.026. Epub 2016 Feb 10.
PMID: 26936039
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Won Ho Kim, MD
investigator title: Clinical Associate Professor
mesh term: Kidney Neoplasms
sharing ipd: No