NCT01260259

Seattle Cardiorenal Remote Ischemic Preconditioning Trial

Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory and cell survival pathways, and thus protect remote organs against future ischemic injury. We hypothesize that compared to sham treatment, RIPC will be associated with decreased post-operative acute kidney, myocardial, and lung injury.

Detailed description

In children undergoing cardiac surgery and cardiopulmonary bypass (CPB), our primary aims are to determine whether RPC is associated with: 1) decreased AKI and 2) decreased acute myocardial injury. Secondary aims include investigating the effects of RPC on post-procedure: 1)acute lung injury and 2) morbidity/mortality.

Conditions

• Congenital Heart Disease
• Cardiopulmonary Bypass
• Myocardial Injury
• Acute Kidney Injury
• Acute Lung Injury

Interventions

Type	Name	Description
PROCEDURE	RIPC	RIPC will be elicited in the operating room (OR) after anesthesia induction and before start of surgery. After placement of an arterial line, a tourniquet will be placed over a lower extremity. It will be inflated to 15 mmHg above systolic blood pressure for 5 minutes, and then deflated for 5 minutes. This cycle of inflation-deflation will be repeated another 3 times before surgery.
PROCEDURE	Control	In OR, after induction of general anesthesia and arterial line placement, a deflated tourniquet will be placed over the lower extremity for 40 minutes.

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2010-12-15
• Last updated: 2013-09-18

Locations

1 site across 1 country: United States