Acute Kidney Injury Clinical Trial
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
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.
n/a
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