NCT01067703

Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

Remote Ischaemic Preconditioning for Heart Surgery

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,400 (actual)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in patients undergoing cardiac surgery compared to control intervention.

Detailed description

Cardiac surgery with cardiopulmonary bypass is associated with a predictable incidence of myocardial, neurological and renal dysfunction. This significant morbidity and mortality is at least partly due to perioperative ischaemia. Remote ischaemic preconditioning (RIPC) is a novel, simple, non-invasive and inexpensive intervention by which ischaemia of non-vital tissue (skeletal muscles) protects remote organs (heart, brain and kidney) from a subsequent sustained episode of ischaemia. The investigators perform a multicenter randomized controlled study to evaluate that RIPC reduces teh severity of perioperative ischaemic injury in patients undergoing cardiac surgery, and results in about 1/3 risk reduction in the occurence of major adverse events.

Conditions

• Myocardial Injury
• Mortality

Interventions

Type	Name	Description
PROCEDURE	Remote Ischemic Preconditioning	RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200 mm Hg, whereas the pressure has to be at least 20 mm Hg greater than the systolic arterial pressure measured via the arterial line.
PROCEDURE	Control/sham procedure (blood pressure cuff)	Sham placement of the blood pressure cuff around a dummy arm inflated to a pressure of 200 mm Hg with four cycles of 5 min inflation and 5 min deflation.

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-05-01
• Completion: 2015-05-01
• First posted: 2010-02-11
• Last updated: 2015-12-03

Locations

10 sites across 1 country: Germany