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

October 21, 2017 updated by: Sina Bagheri, Shiraz University of Medical Sciences

Effect of Remote Ischemic Preconditioning on the Incidence of Acute Kidney Injury in Patients Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within the first 72 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of hospital stay
Time Frame: Through hospital stay after surgery, an average of 5 days
Through hospital stay after surgery, an average of 5 days
Duration of ICU stay
Time Frame: Through ICU stay, an average of 3 days
Through ICU stay, an average of 3 days
All cause mortality
Time Frame: Through hospital stay after surgery, an average of 5 days
Through hospital stay after surgery, an average of 5 days
Number of participants requiring dialysis
Time Frame: Through hospital stay after surgery, an average of 5 days
Through hospital stay after surgery, an average of 5 days
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
Preoperatively and at 24 h post-surgery
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
Within the first 72 hours after surgery
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
Through hospital stay after surgery, an average of 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Investigators

  • Study Chair: Mohammad Mahdi Sagheb, MD, Department of Nephrology, Shiraz University of Medical Sciences, Shiraz, Iran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 21, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 94-01-01-11214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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