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Research

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Remote IMPACT

Official Title

Remote IscheMic Preconditioning in CArdiAc Surgery Trial

Status

Completed

Overview

To determine the effect of remote ischemic preconditioning (RIPC) on surrogate endpoints of cardiac and kidney injury and determine what combination of limbs used and number of cycles is most effective.

Study Design

Randomized, double-blind, multicentre, controlled trial of 2 parallel groups (1 sham control and 1 active regimen of remote ischemic preconditioning). Patients may be co-enrolled with the SIRS trial and will be stratified by SIRS allocation (Methylprednisolone or a matching placebo).

Primary Endpoint

Primary Outcome Measures
1) recruitment rate per centre
2) follow-up completeness at 30 days and 6 months after surgery

Secondary Outcome Measures
1) Peak change in CK-MB in the first 24 hours after surgery
2) Peak change in serum creatinine in the first 4 days after surgery
3) Number of days in the intensive care unit and in hospital after surgery
4) Incidence of death from any cause at 30 days after surgery
5) Incidence of new dialysis required within 30 days after surgery
6) Incidence of documented myocardial infarction at 30 days after surgery
7) Incidence of documented stroke at 30 days after surgery

Number of Patients

258

Number of Sites

10

Number of Countries

4

Study Period

2011–2012

Principal Investigator

P.J. Devereaux

Program Manager

Susan Chrolavicius, Shirley Pettit

Research Coordinator

Jessica Vincent