<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/NCT02981680</url>
  </required_header>
  <id_info>
    <org_study_id>94-01-01-11214</org_study_id>
    <nct_id>NCT02981680</nct_id>
  </id_info>
  <brief_title>Effect of Remote Ischemic Preconditioning on the Incidence of Acute Kidney Injury in Patients Undergoing Coronary Artery Bypass Graft Surgery</brief_title>
  <official_title>Effect of Remote Ischemic Preconditioning on the Incidence of Acute Kidney Injury in Patients Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shiraz University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shiraz University of Medical Sciences</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Acute kidney injury (AKI) following coronary artery bypass graft (CABG) surgery is a major&#xD;
      complication occurring in 1% to 53% of patients (depending on how it is defined) with the&#xD;
      pooled rate of 18.2% and unfortunately 2.1% of them require renal replacement therapy.&#xD;
      Cardiopulmonary bypass (CPB)-associated AKI increases mortality 2-4 fold regardless of AKI&#xD;
      definition. It is also associated with increased risk of postoperative stroke, acute&#xD;
      myocardial infarction, cardiac tamponade, heart failure, and lengthened intensive care unit&#xD;
      and hospital stays. Even minor elevations of postoperative serum creatinine (SCr) have been&#xD;
      associated with a significant increase in 30-day mortality, from a 3-fold increase risk for a&#xD;
      small elevation of up to 0.5 mg/dL from baseline to an 18-fold increase risk of death with a&#xD;
      SCr rise greater than 0.5 mg/dL.&#xD;
&#xD;
      The pathogenesis of CPB-associated AKI is complicated and includes hemodynamic, inflammatory&#xD;
      and other mechanisms that interact at a cellular level. To date, despite several clinical&#xD;
      trials of pharmacologic interventions, none of them have demonstrated conclusively efficacy&#xD;
      in the prevention of AKI after cardiac surgery.&#xD;
&#xD;
      Remote ischemic preconditioning (RIPC) is a phenomenon in which brief ischemia of one organ&#xD;
      or tissue, provokes a protective effect that can reduce the mass of infarction caused by&#xD;
      vessel occlusion and reperfusion. In CABG surgery, cardiomyocyte injury caused by myocardial&#xD;
      protection failure is predominantly responsible for adverse outcomes. RIPC was shown to&#xD;
      reduce troponin release 24 h postoperatively in children undergoing corrective surgery for&#xD;
      congenital heart disease. Other studies demonstrated that RIPC using brief ischemia and&#xD;
      reperfusion of the upper limb reduces myocardial injury in adult patients undergoing CABG&#xD;
      surgery.&#xD;
&#xD;
      Due to the similarities between the mechanisms of ischemia-reperfusion injury produced by&#xD;
      RIPC and those proposed for AKI after CPB, we decided to test the hypothesis that RIPC&#xD;
      prevents AKI in patients undergoing CABG surgery.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      180 patients who fulfill all inclusion and exclusion criteria will be divided into case and&#xD;
      control groups (90 patients in the case and 90 patients in the control group).&#xD;
&#xD;
      Patients in the treatment group will receive three sequential sphygmomanometer cuff&#xD;
      inflations on their right upper arm after induction of anesthesia in the operating room. The&#xD;
      cuff will be inflated by the OR nurse up to 200 mmHg for five minutes each occasion, with&#xD;
      five minutes deflation in between inflations. Following this pre-conditioning phase, surgery&#xD;
      will be started. The entire pre-conditioning phase will last 30 minutes.&#xD;
&#xD;
      Patients in the control group will have the sphygmomanometer cuff placed on their right upper&#xD;
      arm, but the cuff will not be inflated. Similar to patients in the treatment group, patients&#xD;
      in the control group will undergo the same 30 minute delay before starting surgery.&#xD;
&#xD;
      Complete blood count (CBC), SCr, liver function test (LFT), will be checked before surgery.&#xD;
&#xD;
      After surgery, SCr will be checked daily. If AKI occurs, it will be managed and dialysis will&#xD;
      be done if the patient requires it. All patients will undergo electrocardiogram and LFT after&#xD;
      CABG surgery during hospital course.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2013</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of postoperative acute kidney injury (AKI)</measure>
    <time_frame>Within the first 72 hours after surgery</time_frame>
    <description>Defined as an elevation of serum creatinine of ≥0.3 mg/dl or ≥50% within 72 hours after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>Through hospital stay after surgery, an average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of ICU stay</measure>
    <time_frame>Through ICU stay, an average of 3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>Through hospital stay after surgery, an average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants requiring dialysis</measure>
    <time_frame>Through hospital stay after surgery, an average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative liver function</measure>
    <time_frame>Preoperatively and at 24 h post-surgery</time_frame>
    <description>By measuring serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL), and albumin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of postoperative atrial fibrillation (AF)</measure>
    <time_frame>Within the first 72 hours after surgery</time_frame>
    <description>Defined as the incidence of new-onset AF lasting for five minutes or longer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of postoperative stroke</measure>
    <time_frame>Through hospital stay after surgery, an average of 5 days</time_frame>
    <description>Defined as a new ischemic or hemorrhagic cerebrovascular accident with neurological deficit lasting &gt;24 h</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Acute Kidney Injury</condition>
  <condition>Coronary Artery Bypass</condition>
  <condition>Ischemic Preconditioning</condition>
  <arm_group>
    <arm_group_label>RIPC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the remote ischemic preconditioning (RIPC) group will receive three sequential sphygmomanometer cuff inflations on their right upper arm after induction of anesthesia in the operating room. The cuff will be inflated by the OR nurse up to 200 mmHg for five minutes each occasion, with five minutes deflation in between inflations. Following this pre-conditioning phase, surgery will be started. The entire pre-conditioning phase will last 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham-RIPC</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients in the sham-RIPC group will have the sphygmomanometer cuff placed on their right upper arm, but the cuff will not be inflated. Similar to patients in the RIPC group, patients in the sham-RIPC group will undergo the same 30 minute delay before starting surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Remote Ischemic Preconditioning (RIPC)</intervention_name>
    <description>Remote ischemic preconditioning (RIPC) is a phenomenon in which brief ischemia of one organ or tissue, provokes a protective effect that can reduce the mass of infarction caused by vessel occlusion and reperfusion.</description>
    <arm_group_label>RIPC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sham-RIPC</intervention_name>
    <arm_group_label>sham-RIPC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Candidate cardiac surgical patients&#xD;
&#xD;
          -  Elective or urgent on pump coronary artery bypass grafting (CABG)&#xD;
&#xD;
          -  Age 18 to 85 years&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  End-stage renal disease (receiving hemodialysis or glomerular filtration rate &lt;15&#xD;
             ml/min/1.73m2)&#xD;
&#xD;
          -  Peripheral vascular disease&#xD;
&#xD;
          -  Severe hepatic disease&#xD;
&#xD;
          -  Planned off-pump surgery&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammad Mahdi Sagheb, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Nephrology, Shiraz University of Medical Sciences, Shiraz, Iran</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shiraz University of Medical Sciences</name>
      <address>
        <city>Shiraz</city>
        <state>Fars</state>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <reference>
    <citation>Pickering JW, James MT, Palmer SC. Acute kidney injury and prognosis after cardiopulmonary bypass: a meta-analysis of cohort studies. Am J Kidney Dis. 2015 Feb;65(2):283-93. doi: 10.1053/j.ajkd.2014.09.008. Epub 2014 Nov 5.</citation>
    <PMID>25445101</PMID>
  </reference>
  <reference>
    <citation>Karkouti K, Wijeysundera DN, Yau TM, Callum JL, Cheng DC, Crowther M, Dupuis JY, Fremes SE, Kent B, Laflamme C, Lamy A, Legare JF, Mazer CD, McCluskey SA, Rubens FD, Sawchuk C, Beattie WS. Acute kidney injury after cardiac surgery: focus on modifiable risk factors. Circulation. 2009 Feb 3;119(4):495-502. doi: 10.1161/CIRCULATIONAHA.108.786913. Epub 2009 Jan 19.</citation>
    <PMID>19153273</PMID>
  </reference>
  <reference>
    <citation>Gallagher S, Jones DA, Lovell MJ, Hassan S, Wragg A, Kapur A, Uppal R, Yaqoob MM. The impact of acute kidney injury on midterm outcomes after coronary artery bypass graft surgery: a matched propensity score analysis. J Thorac Cardiovasc Surg. 2014 Mar;147(3):989-95. doi: 10.1016/j.jtcvs.2013.03.016. Epub 2013 Apr 12.</citation>
    <PMID>23587469</PMID>
  </reference>
  <reference>
    <citation>Ryden L, Ahnve S, Bell M, Hammar N, Ivert T, Holzmann MJ. Acute kidney injury following coronary artery bypass grafting: early mortality and postoperative complications. Scand Cardiovasc J. 2012 Apr;46(2):114-20. doi: 10.3109/14017431.2012.657229. Epub 2012 Feb 10.</citation>
    <PMID>22324648</PMID>
  </reference>
  <reference>
    <citation>Mehta RH, Honeycutt E, Patel UD, Lopes RD, Shaw LK, Glower DD, Harrington RA, Califf RM, Sketch MH Jr. Impact of recovery of renal function on long-term mortality after coronary artery bypass grafting. Am J Cardiol. 2010 Dec 15;106(12):1728-34. doi: 10.1016/j.amjcard.2010.07.045. Epub 2010 Oct 26.</citation>
    <PMID>21126617</PMID>
  </reference>
  <reference>
    <citation>Loef BG, Epema AH, Smilde TD, Henning RH, Ebels T, Navis G, Stegeman CA. Immediate postoperative renal function deterioration in cardiac surgical patients predicts in-hospital mortality and long-term survival. J Am Soc Nephrol. 2005 Jan;16(1):195-200. doi: 10.1681/ASN.2003100875. Epub 2004 Nov 24.</citation>
    <PMID>15563558</PMID>
  </reference>
  <reference>
    <citation>Olsson D, Sartipy U, Braunschweig F, Holzmann MJ. Acute kidney injury following coronary artery bypass surgery and long-term risk of heart failure. Circ Heart Fail. 2013 Jan;6(1):83-90. doi: 10.1161/CIRCHEARTFAILURE.112.971705. Epub 2012 Dec 10.</citation>
    <PMID>23230310</PMID>
  </reference>
  <reference>
    <citation>Dasta JF, Kane-Gill SL, Durtschi AJ, Pathak DS, Kellum JA. Costs and outcomes of acute kidney injury (AKI) following cardiac surgery. Nephrol Dial Transplant. 2008 Jun;23(6):1970-4. doi: 10.1093/ndt/gfm908. Epub 2008 Jan 4.</citation>
    <PMID>18178605</PMID>
  </reference>
  <reference>
    <citation>Lassnigg A, Schmidlin D, Mouhieddine M, Bachmann LM, Druml W, Bauer P, Hiesmayr M. Minimal changes of serum creatinine predict prognosis in patients after cardiothoracic surgery: a prospective cohort study. J Am Soc Nephrol. 2004 Jun;15(6):1597-605. doi: 10.1097/01.asn.0000130340.93930.dd.</citation>
    <PMID>15153571</PMID>
  </reference>
  <reference>
    <citation>Rosner MH, Okusa MD. Acute kidney injury associated with cardiac surgery. Clin J Am Soc Nephrol. 2006 Jan;1(1):19-32. doi: 10.2215/CJN.00240605. Epub 2005 Oct 19.</citation>
    <PMID>17699187</PMID>
  </reference>
  <reference>
    <citation>Burns KE, Chu MW, Novick RJ, Fox SA, Gallo K, Martin CM, Stitt LW, Heidenheim AP, Myers ML, Moist L. Perioperative N-acetylcysteine to prevent renal dysfunction in high-risk patients undergoing cabg surgery: a randomized controlled trial. JAMA. 2005 Jul 20;294(3):342-50. doi: 10.1001/jama.294.3.342.</citation>
    <PMID>16030279</PMID>
  </reference>
  <reference>
    <citation>Young EW, Diab A, Kirsh MM. Intravenous diltiazem and acute renal failure after cardiac operations. Ann Thorac Surg. 1998 May;65(5):1316-9. doi: 10.1016/s0003-4975(98)00157-x.</citation>
    <PMID>9594859</PMID>
  </reference>
  <reference>
    <citation>Ranucci M, Soro G, Barzaghi N, Locatelli A, Giordano G, Vavassori A, Manzato A, Melchiorri C, Bove T, Juliano G, Uslenghi MF. Fenoldopam prophylaxis of postoperative acute renal failure in high-risk cardiac surgery patients. Ann Thorac Surg. 2004 Oct;78(4):1332-7; discussion 1337-8. doi: 10.1016/j.athoracsur.2004.02.065.</citation>
    <PMID>15464494</PMID>
  </reference>
  <reference>
    <citation>Venugopal V, Ludman A, Yellon DM, Hausenloy DJ. 'Conditioning' the heart during surgery. Eur J Cardiothorac Surg. 2009 Jun;35(6):977-87. doi: 10.1016/j.ejcts.2009.02.014. Epub 2009 Mar 25. Erratum In: Eur J Cardiothorac Surg. 2009 Sep;36(3):608.</citation>
    <PMID>19324569</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>Venugopal V, Hausenloy DJ, Ludman A, Di Salvo C, Kolvekar S, Yap J, Lawrence D, Bognolo J, Yellon DM. Remote ischaemic preconditioning reduces myocardial injury in patients undergoing cardiac surgery with cold-blood cardioplegia: a randomised controlled trial. Heart. 2009 Oct;95(19):1567-71. doi: 10.1136/hrt.2008.155770. Epub 2009 Jun 8.</citation>
    <PMID>19508973</PMID>
  </reference>
  <reference>
    <citation>Bonventre JV, Zuk A. Ischemic acute renal failure: an inflammatory disease? Kidney Int. 2004 Aug;66(2):480-5. doi: 10.1111/j.1523-1755.2004.761_2.x.</citation>
    <PMID>15253693</PMID>
  </reference>
  <reference>
    <citation>Yellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med. 2007 Sep 13;357(11):1121-35. doi: 10.1056/NEJMra071667. No abstract available.</citation>
    <PMID>17855673</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>October 21, 2017</last_update_submitted>
  <last_update_submitted_qc>October 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shiraz University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Sina Bagheri</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>remote ischemic preconditioning; transient limb ischemia; acute kidney injury; coronary artery bypass graft surgery</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>
  <!-- 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/NCT02981680
org study id: 94-01-01-11214
nct id: NCT02981680
lead sponsor: 
Background:

      Acute kidney injury (AKI) following coronary artery bypass graft (CABG) surgery is a major
      complication occurring in 1% to 53% of patients (depending on how it is defined) with the
      pooled rate of 18.2% and unfortunately 2.1% of them require renal replacement therapy.
      Cardiopulmonary bypass (CPB)-associated AKI increases mortality 2-4 fold regardless of AKI
      definition. It is also associated with increased risk of postoperative stroke, acute
      myocardial infarction, cardiac tamponade, heart failure, and lengthened intensive care unit
      and hospital stays. Even minor elevations of postoperative serum creatinine (SCr) have been
      associated with a significant increase in 30-day mortality, from a 3-fold increase risk for a
      small elevation of up to 0.5 mg/dL from baseline to an 18-fold increase risk of death with a
      SCr rise greater than 0.5 mg/dL.

      The pathogenesis of CPB-associated AKI is complicated and includes hemodynamic, inflammatory
      and other mechanisms that interact at a cellular level. To date, despite several clinical
      trials of pharmacologic interventions, none of them have demonstrated conclusively efficacy
      in the prevention of AKI after cardiac surgery.

      Remote ischemic preconditioning (RIPC) is a phenomenon in which brief ischemia of one organ
      or tissue, provokes a protective effect that can reduce the mass of infarction caused by
      vessel occlusion and reperfusion. In CABG surgery, cardiomyocyte injury caused by myocardial
      protection failure is predominantly responsible for adverse outcomes. RIPC was shown to
      reduce troponin release 24 h postoperatively in children undergoing corrective surgery for
      congenital heart disease. Other studies demonstrated that RIPC using brief ischemia and
      reperfusion of the upper limb reduces myocardial injury in adult patients undergoing CABG
      surgery.

      Due to the similarities between the mechanisms of ischemia-reperfusion injury produced by
      RIPC and those proposed for AKI after CPB, we decided to test the hypothesis that RIPC
      prevents AKI in patients undergoing CABG surgery.

      Methods:

      180 patients who fulfill all inclusion and exclusion criteria will be divided into case and
      control groups (90 patients in the case and 90 patients in the control group).

      Patients in the treatment group will receive three sequential sphygmomanometer cuff
      inflations on their right upper arm after induction of anesthesia in the operating room. The
      cuff will be inflated by the OR nurse up to 200 mmHg for five minutes each occasion, with
      five minutes deflation in between inflations. Following this pre-conditioning phase, surgery
      will be started. The entire pre-conditioning phase will last 30 minutes.

      Patients in the control group will have the sphygmomanometer cuff placed on their right upper
      arm, but the cuff will not be inflated. Similar to patients in the treatment group, patients
      in the control group will undergo the same 30 minute delay before starting surgery.

      Complete blood count (CBC), SCr, liver function test (LFT), will be checked before surgery.

      After surgery, SCr will be checked daily. If AKI occurs, it will be managed and dialysis will
      be done if the patient requires it. All patients will undergo electrocardiogram and LFT after
      CABG surgery during hospital course.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of postoperative acute kidney injury (AKI)
time frame: Within the first 72 hours after surgery
description: Defined as an elevation of serum creatinine of ≥0.3 mg/dl or ≥50% within 72 hours after surgery
measure: Duration of hospital stay
time frame: Through hospital stay after surgery, an average of 5 days
measure: Duration of ICU stay
time frame: Through ICU stay, an average of 3 days
measure: All cause mortality
time frame: Through hospital stay after surgery, an average of 5 days
measure: Number of participants requiring dialysis
time frame: Through hospital stay after surgery, an average of 5 days
measure: Postoperative liver function
time frame: Preoperatively and at 24 h post-surgery
description: By measuring serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL), and albumin
measure: Incidence of postoperative atrial fibrillation (AF)
time frame: Within the first 72 hours after surgery
description: Defined as the incidence of new-onset AF lasting for five minutes or longer
measure: Incidence of postoperative stroke
time frame: Through hospital stay after surgery, an average of 5 days
description: Defined as a new ischemic or hemorrhagic cerebrovascular accident with neurological deficit lasting >24 h
arm group label: RIPC
arm group type: Experimental
description: Patients in the remote ischemic preconditioning (RIPC) group will receive three sequential sphygmomanometer cuff inflations on their right upper arm after induction of anesthesia in the operating room. The cuff will be inflated by the OR nurse up to 200 mmHg for five minutes each occasion, with five minutes deflation in between inflations. Following this pre-conditioning phase, surgery will be started. The entire pre-conditioning phase will last 30 minutes.
arm group label: sham-RIPC
arm group type: Sham Comparator
description: Patients in the sham-RIPC group will have the sphygmomanometer cuff placed on their right upper arm, but the cuff will not be inflated. Similar to patients in the RIPC group, patients in the sham-RIPC group will undergo the same 30 minute delay before starting surgery.
intervention type: Procedure
intervention name: Remote Ischemic Preconditioning (RIPC)
description: Remote ischemic preconditioning (RIPC) is a phenomenon in which brief ischemia of one organ or tissue, provokes a protective effect that can reduce the mass of infarction caused by vessel occlusion and reperfusion.
arm group label: RIPC
intervention type: Procedure
intervention name: sham-RIPC
arm group label: sham-RIPC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Mohammad Mahdi Sagheb, MD
role: Study Chair
affiliation: Department of Nephrology, Shiraz University of Medical Sciences, Shiraz, Iran
facility: 
country: Iran, Islamic Republic of
citation: Pickering JW, James MT, Palmer SC. Acute kidney injury and prognosis after cardiopulmonary bypass: a meta-analysis of cohort studies. Am J Kidney Dis. 2015 Feb;65(2):283-93. doi: 10.1053/j.ajkd.2014.09.008. Epub 2014 Nov 5.
PMID: 25445101
citation: Karkouti K, Wijeysundera DN, Yau TM, Callum JL, Cheng DC, Crowther M, Dupuis JY, Fremes SE, Kent B, Laflamme C, Lamy A, Legare JF, Mazer CD, McCluskey SA, Rubens FD, Sawchuk C, Beattie WS. Acute kidney injury after cardiac surgery: focus on modifiable risk factors. Circulation. 2009 Feb 3;119(4):495-502. doi: 10.1161/CIRCULATIONAHA.108.786913. Epub 2009 Jan 19.
PMID: 19153273
citation: Gallagher S, Jones DA, Lovell MJ, Hassan S, Wragg A, Kapur A, Uppal R, Yaqoob MM. The impact of acute kidney injury on midterm outcomes after coronary artery bypass graft surgery: a matched propensity score analysis. J Thorac Cardiovasc Surg. 2014 Mar;147(3):989-95. doi: 10.1016/j.jtcvs.2013.03.016. Epub 2013 Apr 12.
PMID: 23587469
citation: Ryden L, Ahnve S, Bell M, Hammar N, Ivert T, Holzmann MJ. Acute kidney injury following coronary artery bypass grafting: early mortality and postoperative complications. Scand Cardiovasc J. 2012 Apr;46(2):114-20. doi: 10.3109/14017431.2012.657229. Epub 2012 Feb 10.
PMID: 22324648
citation: Mehta RH, Honeycutt E, Patel UD, Lopes RD, Shaw LK, Glower DD, Harrington RA, Califf RM, Sketch MH Jr. Impact of recovery of renal function on long-term mortality after coronary artery bypass grafting. Am J Cardiol. 2010 Dec 15;106(12):1728-34. doi: 10.1016/j.amjcard.2010.07.045. Epub 2010 Oct 26.
PMID: 21126617
citation: Loef BG, Epema AH, Smilde TD, Henning RH, Ebels T, Navis G, Stegeman CA. Immediate postoperative renal function deterioration in cardiac surgical patients predicts in-hospital mortality and long-term survival. J Am Soc Nephrol. 2005 Jan;16(1):195-200. doi: 10.1681/ASN.2003100875. Epub 2004 Nov 24.
PMID: 15563558
citation: Olsson D, Sartipy U, Braunschweig F, Holzmann MJ. Acute kidney injury following coronary artery bypass surgery and long-term risk of heart failure. Circ Heart Fail. 2013 Jan;6(1):83-90. doi: 10.1161/CIRCHEARTFAILURE.112.971705. Epub 2012 Dec 10.
PMID: 23230310
citation: Dasta JF, Kane-Gill SL, Durtschi AJ, Pathak DS, Kellum JA. Costs and outcomes of acute kidney injury (AKI) following cardiac surgery. Nephrol Dial Transplant. 2008 Jun;23(6):1970-4. doi: 10.1093/ndt/gfm908. Epub 2008 Jan 4.
PMID: 18178605
citation: Lassnigg A, Schmidlin D, Mouhieddine M, Bachmann LM, Druml W, Bauer P, Hiesmayr M. Minimal changes of serum creatinine predict prognosis in patients after cardiothoracic surgery: a prospective cohort study. J Am Soc Nephrol. 2004 Jun;15(6):1597-605. doi: 10.1097/01.asn.0000130340.93930.dd.
PMID: 15153571
citation: Rosner MH, Okusa MD. Acute kidney injury associated with cardiac surgery. Clin J Am Soc Nephrol. 2006 Jan;1(1):19-32. doi: 10.2215/CJN.00240605. Epub 2005 Oct 19.
PMID: 17699187
citation: Burns KE, Chu MW, Novick RJ, Fox SA, Gallo K, Martin CM, Stitt LW, Heidenheim AP, Myers ML, Moist L. Perioperative N-acetylcysteine to prevent renal dysfunction in high-risk patients undergoing cabg surgery: a randomized controlled trial. JAMA. 2005 Jul 20;294(3):342-50. doi: 10.1001/jama.294.3.342.
PMID: 16030279
citation: Young EW, Diab A, Kirsh MM. Intravenous diltiazem and acute renal failure after cardiac operations. Ann Thorac Surg. 1998 May;65(5):1316-9. doi: 10.1016/s0003-4975(98)00157-x.
PMID: 9594859
citation: Ranucci M, Soro G, Barzaghi N, Locatelli A, Giordano G, Vavassori A, Manzato A, Melchiorri C, Bove T, Juliano G, Uslenghi MF. Fenoldopam prophylaxis of postoperative acute renal failure in high-risk cardiac surgery patients. Ann Thorac Surg. 2004 Oct;78(4):1332-7; discussion 1337-8. doi: 10.1016/j.athoracsur.2004.02.065.
PMID: 15464494
citation: Venugopal V, Ludman A, Yellon DM, Hausenloy DJ. 'Conditioning' the heart during surgery. Eur J Cardiothorac Surg. 2009 Jun;35(6):977-87. doi: 10.1016/j.ejcts.2009.02.014. Epub 2009 Mar 25. Erratum In: Eur J Cardiothorac Surg. 2009 Sep;36(3):608.
PMID: 19324569
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: Venugopal V, Hausenloy DJ, Ludman A, Di Salvo C, Kolvekar S, Yap J, Lawrence D, Bognolo J, Yellon DM. Remote ischaemic preconditioning reduces myocardial injury in patients undergoing cardiac surgery with cold-blood cardioplegia: a randomised controlled trial. Heart. 2009 Oct;95(19):1567-71. doi: 10.1136/hrt.2008.155770. Epub 2009 Jun 8.
PMID: 19508973
citation: Bonventre JV, Zuk A. Ischemic acute renal failure: an inflammatory disease? Kidney Int. 2004 Aug;66(2):480-5. doi: 10.1111/j.1523-1755.2004.761_2.x.
PMID: 15253693
citation: Yellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med. 2007 Sep 13;357(11):1121-35. doi: 10.1056/NEJMra071667. No abstract available.
PMID: 17855673
responsible party type: Principal Investigator
investigator affiliation: Shiraz University of Medical Sciences
investigator full name: Sina Bagheri
investigator title: Principal Investigator
mesh term: Acute Kidney Injury
mesh term: Ischemia
mesh term: Wounds and Injuries