<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/NCT03238391</url>
  </required_header>
  <id_info>
    <org_study_id>kügokaek2017/51</org_study_id>
    <nct_id>NCT03238391</nct_id>
  </id_info>
  <brief_title>Ischemic Preconditioning for Prevention of Contrast Nephropathy in The Emergency Department</brief_title>
  <official_title>Ischemic Preconditioning for Prevention of Contrast Nephropathy in The Emergency Department: Randomised, Double Blind Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Derince Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Derince Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to demonstrate the effectiveness of ischemic preconditioning in&#xD;
      the emergency department to prevent contrast induced nephropathy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research will be conducted of emergency medicine department in The Derince Training and&#xD;
      Research Hospital. Patients ages 18 and older, who will be received contrast enhanced CT scan&#xD;
      in the emergency medicine department will be included to the study. Patients will be excluded&#xD;
      from the study if The Mehran Risk Score is under 6 points. The Mehran Risk Score is a scoring&#xD;
      system for prediction of contrast-induced nephropathy. This CIN (Contrast induced&#xD;
      nephropathy) risk stratification score based on 8 variables. The variables included in the&#xD;
      CIN risk score are: 1) patient-related characteristics (i.e., age &gt;75 years, diabetes&#xD;
      mellitus, chronic congestive heart failure, or admission with acute pulmonary edema,&#xD;
      hypotension, anemia, and chronic kidney disease); and 2) procedure related characteristics&#xD;
      (i.e., the use of elective IABP (Intra aortic balloon pump) or increasing volumes of contrast&#xD;
      media). It is categorized into 4 groups according to MRS (Mehran Risk Score) (low-risk: 5&#xD;
      (7.5%); medium-risk: 6-10 (14%); high-risk: 11-16 (26.1%); and very high-risk: 16&#xD;
      (57.3%).Normal salin at a rate of 3 mL/kg/hour per 1 hour before contrast agents exposure&#xD;
      followed by 1 mL/kg/hour for 6 hours after the procedure is administered whose Mehran risk&#xD;
      score is greater than 6 in our daily practice. Patients with risk factors for CIN are&#xD;
      recommended about the necessity of follow-up care with their physicians within 48-72 hours.&#xD;
      Patients with low risk of contrast induced nephropathy, previous allergic reactions to&#xD;
      contrast material, hemodynamically unstable and require excessive fluid resuscitation,&#xD;
      undergoing surgical procedures, require renal-replacement therapy, who refuse to participate&#xD;
      the study will be excluded. All of the emergency medicine physicians will be informed of the&#xD;
      study. Participants were randomly assigned into two groups with a 1:1 allocation following&#xD;
      simple randomization procedures by a program (www.randomization.com) generating an online&#xD;
      random number. All participating patients will receive the standard hydration schedule as&#xD;
      mentioned before. Patients in the study group will receive ischemia and reperfusion of the&#xD;
      arm by inflating a blood pressure cuff around the arm at 50 mmHg above the systolic blood&#xD;
      pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated&#xD;
      three times. Patients in sham group, will receive ischemia and reperfusion of the arm by&#xD;
      inflating a blood pressure cuff around the arm at 10 mmHg below the diastolic blood pressure&#xD;
      for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three&#xD;
      times. The allocation sequence will be concealed from the researchers and participants in&#xD;
      sealed, sequentially numbered envelopes. Envelopes will be opened by the nurse who will&#xD;
      administer the protocol. Less than 100 mL of nonionic, hypoosmolar contrast agent will be&#xD;
      injected in all CT scans.All of the participants will be recommended about the necessity of&#xD;
      follow-up care with their physicians within 48-72 hours. Participants will be called 72 hours&#xD;
      after the treatment. Patients who are diagnosed with CIN will be followed for one month to&#xD;
      see whether they will develop renal failure requiring renal replacement therapy. After 72&#xD;
      hours the laboratory results will be recorded by the researchers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 15, 2017</start_date>
  <completion_date type="Anticipated">February 15, 2018</completion_date>
  <primary_completion_date type="Anticipated">February 15, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants developing contrast-induced nephropathy</measure>
    <time_frame>48 to 72 hours</time_frame>
    <description>%25 increase or a greater than 0,5 mg/dl increase in the serum creatinine level, 48 to 72 hours after the administration of contrast agent compared with the baseline creatinine measurement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>renal replacement theraphy</measure>
    <time_frame>1 month</time_frame>
    <description>renal failure necessitating renal replacement therapy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Contrast-induced Nephropathy</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 50 mmHg above the systolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 10 mmHg below the diastolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ischemic preconditioning</intervention_name>
    <description>It is mentioned before in arm/group descriptions</description>
    <arm_group_label>Sham group</arm_group_label>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants, older than 18 years old and received contrast enhanced CT scan in the&#xD;
             emergency medicine department&#xD;
&#xD;
          -  The Mehran Risk Score is greater than 5 points&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The Mehran Risk Score is under 6 points&#xD;
&#xD;
          -  Participants who doesn't want to enroll the study&#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_contact>
    <last_name>Yavuz Yigit, Specialist</last_name>
    <phone>+90 505 6628344</phone>
    <email>dryavuzyigit@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Habeb M, Agac MT, Aliyev F, Pehlivanoglu S, Ongen Z. [Contrast media-induced nephropathy: clinical burden and current attempts for prevention]. Anadolu Kardiyol Derg. 2005 Jun;5(2):124-9. Turkish.</citation>
    <PMID>15939688</PMID>
  </reference>
  <reference>
    <citation>McCullough PA, Choi JP, Feghali GA, Schussler JM, Stoler RM, Vallabahn RC, Mehta A. Contrast-Induced Acute Kidney Injury. J Am Coll Cardiol. 2016 Sep 27;68(13):1465-1473. doi: 10.1016/j.jacc.2016.05.099.</citation>
    <PMID>27659469</PMID>
  </reference>
  <reference>
    <citation>Kelly AM, Dwamena B, Cronin P, Bernstein SJ, Carlos RC. Meta-analysis: effectiveness of drugs for preventing contrast-induced nephropathy. Ann Intern Med. 2008 Feb 19;148(4):284-94. doi: 10.7326/0003-4819-148-4-200802190-00007. Erratum In: Ann Intern Med. 2008 Aug 5;149(3):219.</citation>
    <PMID>18283206</PMID>
  </reference>
  <reference>
    <citation>Marenzi G, Bartorelli AL. Recent advances in the prevention of radiocontrast-induced nephropathy. Curr Opin Crit Care. 2004 Dec;10(6):505-9. doi: 10.1097/01.ccx.0000145098.13199.e8.</citation>
    <PMID>15616393</PMID>
  </reference>
  <reference>
    <citation>Barreto R. Prevention of contrast-induced nephropathy: the rational use of sodium bicarbonate. Nephrol Nurs J. 2007 Jul-Aug;34(4):417-21.</citation>
    <PMID>17891910</PMID>
  </reference>
  <reference>
    <citation>Asif A, Garces G, Preston RA, Roth D. Current trials of interventions to prevent radiocontrast-induced nephropathy. Am J Ther. 2005 Mar-Apr;12(2):127-32. doi: 10.1097/01.mjt.0000143694.60662.11.</citation>
    <PMID>15767830</PMID>
  </reference>
  <reference>
    <citation>Ozcan EE, Guneri S, Akdeniz B, Akyildiz IZ, Senaslan O, Baris N, Aslan O, Badak O. Sodium bicarbonate, N-acetylcysteine, and saline for prevention of radiocontrast-induced nephropathy. A comparison of 3 regimens for protecting contrast-induced nephropathy in patients undergoing coronary procedures. A single-center prospective controlled trial. Am Heart J. 2007 Sep;154(3):539-44. doi: 10.1016/j.ahj.2007.05.012.</citation>
    <PMID>17719303</PMID>
  </reference>
  <reference>
    <citation>Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.</citation>
    <PMID>16750696</PMID>
  </reference>
  <reference>
    <citation>Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.</citation>
    <PMID>17707752</PMID>
  </reference>
  <reference>
    <citation>Kharbanda RK, Li J, Konstantinov IE, Cheung MM, White PA, Frndova H, Stokoe J, Cox P, Vogel M, Van Arsdell G, MacAllister R, Redington AN. Remote ischaemic preconditioning protects against cardiopulmonary bypass-induced tissue injury: a preclinical study. Heart. 2006 Oct;92(10):1506-11. doi: 10.1136/hrt.2004.042366. Epub 2006 Jul 3.</citation>
    <PMID>16818489</PMID>
  </reference>
  <reference>
    <citation>Ali ZA, Callaghan CJ, Lim E, Ali AA, Nouraei SA, Akthar AM, Boyle JR, Varty K, Kharbanda RK, Dutka DP, Gaunt ME. Remote ischemic preconditioning reduces myocardial and renal injury after elective abdominal aortic aneurysm repair: a randomized controlled trial. Circulation. 2007 Sep 11;116(11 Suppl):I98-105. doi: 10.1161/circulationaha.106.679167.</citation>
    <PMID>17846333</PMID>
  </reference>
  <reference>
    <citation>Venugopal V, Laing CM, Ludman A, Yellon DM, Hausenloy D. Effect of remote ischemic preconditioning on acute kidney injury in nondiabetic patients undergoing coronary artery bypass graft surgery: a secondary analysis of 2 small randomized trials. Am J Kidney Dis. 2010 Dec;56(6):1043-9. doi: 10.1053/j.ajkd.2010.07.014. Epub 2010 Oct 25.</citation>
    <PMID>20974511</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Derince Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Yavuz Yiğit</investigator_full_name>
    <investigator_title>Emergency medicine specialist</investigator_title>
  </responsible_party>
  <keyword>Contrast-induced nephropathy</keyword>
  <keyword>Ischemic preconditioning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03238391
org study id: kügokaek2017/51
nct id: NCT03238391
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to demonstrate the effectiveness of ischemic preconditioning in
      the emergency department to prevent contrast induced nephropathy
The research will be conducted of emergency medicine department in The Derince Training and
      Research Hospital. Patients ages 18 and older, who will be received contrast enhanced CT scan
      in the emergency medicine department will be included to the study. Patients will be excluded
      from the study if The Mehran Risk Score is under 6 points. The Mehran Risk Score is a scoring
      system for prediction of contrast-induced nephropathy. This CIN (Contrast induced
      nephropathy) risk stratification score based on 8 variables. The variables included in the
      CIN risk score are: 1) patient-related characteristics (i.e., age >75 years, diabetes
      mellitus, chronic congestive heart failure, or admission with acute pulmonary edema,
      hypotension, anemia, and chronic kidney disease); and 2) procedure related characteristics
      (i.e., the use of elective IABP (Intra aortic balloon pump) or increasing volumes of contrast
      media). It is categorized into 4 groups according to MRS (Mehran Risk Score) (low-risk: 5
      (7.5%); medium-risk: 6-10 (14%); high-risk: 11-16 (26.1%); and very high-risk: 16
      (57.3%).Normal salin at a rate of 3 mL/kg/hour per 1 hour before contrast agents exposure
      followed by 1 mL/kg/hour for 6 hours after the procedure is administered whose Mehran risk
      score is greater than 6 in our daily practice. Patients with risk factors for CIN are
      recommended about the necessity of follow-up care with their physicians within 48-72 hours.
      Patients with low risk of contrast induced nephropathy, previous allergic reactions to
      contrast material, hemodynamically unstable and require excessive fluid resuscitation,
      undergoing surgical procedures, require renal-replacement therapy, who refuse to participate
      the study will be excluded. All of the emergency medicine physicians will be informed of the
      study. Participants were randomly assigned into two groups with a 1:1 allocation following
      simple randomization procedures by a program (www.randomization.com) generating an online
      random number. All participating patients will receive the standard hydration schedule as
      mentioned before. Patients in the study group will receive ischemia and reperfusion of the
      arm by inflating a blood pressure cuff around the arm at 50 mmHg above the systolic blood
      pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated
      three times. Patients in sham group, will receive ischemia and reperfusion of the arm by
      inflating a blood pressure cuff around the arm at 10 mmHg below the diastolic blood pressure
      for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three
      times. The allocation sequence will be concealed from the researchers and participants in
      sealed, sequentially numbered envelopes. Envelopes will be opened by the nurse who will
      administer the protocol. Less than 100 mL of nonionic, hypoosmolar contrast agent will be
      injected in all CT scans.All of the participants will be recommended about the necessity of
      follow-up care with their physicians within 48-72 hours. Participants will be called 72 hours
      after the treatment. Patients who are diagnosed with CIN will be followed for one month to
      see whether they will develop renal failure requiring renal replacement therapy. After 72
      hours the laboratory results will be recorded by the researchers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Percentage of Participants developing contrast-induced nephropathy
time frame: 48 to 72 hours
description: %25 increase or a greater than 0,5 mg/dl increase in the serum creatinine level, 48 to 72 hours after the administration of contrast agent compared with the baseline creatinine measurement
measure: renal replacement theraphy
time frame: 1 month
description: renal failure necessitating renal replacement therapy
arm group label: Study group
arm group type: Experimental
description: Patients will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 50 mmHg above the systolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times
arm group label: Sham group
arm group type: Sham Comparator
description: Patients will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 10 mmHg below the diastolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times
intervention type: Procedure
intervention name: Ischemic preconditioning
description: It is mentioned before in arm/group descriptions
arm group label: Sham group
arm group label: Study group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yavuz Yigit, Specialist
phone: +90 505 6628344
email: dryavuzyigit@gmail.com
citation: Habeb M, Agac MT, Aliyev F, Pehlivanoglu S, Ongen Z. [Contrast media-induced nephropathy: clinical burden and current attempts for prevention]. Anadolu Kardiyol Derg. 2005 Jun;5(2):124-9. Turkish.
PMID: 15939688
citation: McCullough PA, Choi JP, Feghali GA, Schussler JM, Stoler RM, Vallabahn RC, Mehta A. Contrast-Induced Acute Kidney Injury. J Am Coll Cardiol. 2016 Sep 27;68(13):1465-1473. doi: 10.1016/j.jacc.2016.05.099.
PMID: 27659469
citation: Kelly AM, Dwamena B, Cronin P, Bernstein SJ, Carlos RC. Meta-analysis: effectiveness of drugs for preventing contrast-induced nephropathy. Ann Intern Med. 2008 Feb 19;148(4):284-94. doi: 10.7326/0003-4819-148-4-200802190-00007. Erratum In: Ann Intern Med. 2008 Aug 5;149(3):219.
PMID: 18283206
citation: Marenzi G, Bartorelli AL. Recent advances in the prevention of radiocontrast-induced nephropathy. Curr Opin Crit Care. 2004 Dec;10(6):505-9. doi: 10.1097/01.ccx.0000145098.13199.e8.
PMID: 15616393
citation: Barreto R. Prevention of contrast-induced nephropathy: the rational use of sodium bicarbonate. Nephrol Nurs J. 2007 Jul-Aug;34(4):417-21.
PMID: 17891910
citation: Asif A, Garces G, Preston RA, Roth D. Current trials of interventions to prevent radiocontrast-induced nephropathy. Am J Ther. 2005 Mar-Apr;12(2):127-32. doi: 10.1097/01.mjt.0000143694.60662.11.
PMID: 15767830
citation: Ozcan EE, Guneri S, Akdeniz B, Akyildiz IZ, Senaslan O, Baris N, Aslan O, Badak O. Sodium bicarbonate, N-acetylcysteine, and saline for prevention of radiocontrast-induced nephropathy. A comparison of 3 regimens for protecting contrast-induced nephropathy in patients undergoing coronary procedures. A single-center prospective controlled trial. Am Heart J. 2007 Sep;154(3):539-44. doi: 10.1016/j.ahj.2007.05.012.
PMID: 17719303
citation: Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.
PMID: 16750696
citation: Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
PMID: 17707752
citation: Kharbanda RK, Li J, Konstantinov IE, Cheung MM, White PA, Frndova H, Stokoe J, Cox P, Vogel M, Van Arsdell G, MacAllister R, Redington AN. Remote ischaemic preconditioning protects against cardiopulmonary bypass-induced tissue injury: a preclinical study. Heart. 2006 Oct;92(10):1506-11. doi: 10.1136/hrt.2004.042366. Epub 2006 Jul 3.
PMID: 16818489
citation: Ali ZA, Callaghan CJ, Lim E, Ali AA, Nouraei SA, Akthar AM, Boyle JR, Varty K, Kharbanda RK, Dutka DP, Gaunt ME. Remote ischemic preconditioning reduces myocardial and renal injury after elective abdominal aortic aneurysm repair: a randomized controlled trial. Circulation. 2007 Sep 11;116(11 Suppl):I98-105. doi: 10.1161/circulationaha.106.679167.
PMID: 17846333
citation: Venugopal V, Laing CM, Ludman A, Yellon DM, Hausenloy D. Effect of remote ischemic preconditioning on acute kidney injury in nondiabetic patients undergoing coronary artery bypass graft surgery: a secondary analysis of 2 small randomized trials. Am J Kidney Dis. 2010 Dec;56(6):1043-9. doi: 10.1053/j.ajkd.2010.07.014. Epub 2010 Oct 25.
PMID: 20974511
responsible party type: Principal Investigator
investigator affiliation: Derince Training and Research Hospital
investigator full name: Yavuz Yiğit
investigator title: Emergency medicine specialist
mesh term: Kidney Diseases
mesh term: Emergencies
sharing ipd: Undecided