Seattle Cardiorenal Remote Ischemic Preconditioning Trial

Not Applicable

Completed

• Conditions: Congenital Heart Disease; Cardiopulmonary Bypass; Myocardial Injury; Acute Kidney Injury; Acute Lung Injury
• Interventions: Procedure: RIPC; Procedure: Control

• Registration Number: NCT01260259
• Lead Sponsor: Seattle Children's Hospital

Brief 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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-15
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Age birth to 18 years Cardiac surgery with planned cardiopulmonary bypass

Exclusion Criteria

Any contraindication to compression of lower extremity/extremities Body weight <2 kg Active infection going into surgery On renal replacement therapy (RRT) or mechanical circulatory support going into surgery On inotropic support going into surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Ischemic Preconditioning (RIPC)	RIPC	-
Control	Control	-

Primary Outcome Measures

Name	Time	Method
Incidence of acute kidney injury (AKI)	72 hours	Serum creatinine (SCr) will be measured at baseline, then on post-operative days 1, 2, and 3.
Incidence of acute myocardial injury	48 hours	Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative.

Secondary Outcome Measures

Name	Time	Method
Biomarkers for AKI	72 hours	Serum and urine will be collected for biomarker discovery.
Incidence of acute lung injury	72 hours and duration of hospitalization	Days on mechanical ventilation, readiness for extubation.
Mortality	Duration of hospitalization, 30 days post-op, and at last follow-up
Hospitalization	Duration of post-operative hospitalization	Number of post-operative days in cardiac intensive care unit (CICU) and hospital.
Inflammation	72 hours	Cytokines will be measured at baseline until 72 hours post-operative.

Trial Locations

Locations (1)

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States