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Effect of Remote Ischemic Preconditioning on the Incidence of Acute Kidney Injury in Patients Undergoing Coronary Artery Bypass Graft Surgery

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ClinicalTrials.gov Identifier: NCT02981680
Recruitment Status : Completed
First Posted : December 5, 2016
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Acute Kidney Injury Coronary Artery Bypass Ischemic Preconditioning Procedure: Remote Ischemic Preconditioning (RIPC) Procedure: sham-RIPC

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 2013
Primary Completion Date : February 2017
Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: RIPC
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.
Procedure: Remote Ischemic Preconditioning (RIPC)
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.
Sham Comparator: sham-RIPC
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.
Procedure: sham-RIPC


Outcome Measures

Primary Outcome Measures :
  1. Incidence of postoperative acute kidney injury (AKI) [ Time Frame: Within the first 72 hours after surgery ]
    Defined as an elevation of serum creatinine of ≥0.3 mg/dl or ≥50% within 72 hours after surgery


Secondary Outcome Measures :
  1. Duration of hospital stay [ Time Frame: Through hospital stay after surgery, an average of 5 days ]
  2. Duration of ICU stay [ Time Frame: Through ICU stay, an average of 3 days ]
  3. All cause mortality [ Time Frame: Through hospital stay after surgery, an average of 5 days ]
  4. Number of participants requiring dialysis [ Time Frame: Through hospital stay after surgery, an average of 5 days ]
  5. Postoperative liver function [ Time Frame: Preoperatively and at 24 h post-surgery ]
    By measuring serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL), and albumin

  6. Incidence of postoperative atrial fibrillation (AF) [ Time Frame: Within the first 72 hours after surgery ]
    Defined as the incidence of new-onset AF lasting for five minutes or longer

  7. Incidence of postoperative stroke [ Time Frame: Through hospital stay after surgery, an average of 5 days ]
    Defined as a new ischemic or hemorrhagic cerebrovascular accident with neurological deficit lasting >24 h


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidate cardiac surgical patients
  • Elective or urgent on pump coronary artery bypass grafting (CABG)
  • Age 18 to 85 years
  • Signed informed consent

Exclusion Criteria:

  • End-stage renal disease (receiving hemodialysis or glomerular filtration rate <15 ml/min/1.73m2)
  • Peripheral vascular disease
  • Severe hepatic disease
  • Planned off-pump surgery
  • Pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981680


Locations
Iran, Islamic Republic of
Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Study Chair: Mohammad Mahdi Sagheb, MD Department of Nephrology, Shiraz University of Medical Sciences, Shiraz, Iran
More Information

Publications:

Responsible Party: Sina Bagheri, Principal Investigator, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02981680     History of Changes
Other Study ID Numbers: 94-01-01-11214
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Keywords provided by Sina Bagheri, Shiraz University of Medical Sciences:
remote ischemic preconditioning; transient limb ischemia; acute kidney injury; coronary artery bypass graft surgery

Additional relevant MeSH terms:
Wounds and Injuries
Ischemia
Acute Kidney Injury
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases