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Seattle Cardiorenal Remote Ischemic Preconditioning Trial (SCRIPT)

Seattle Children's Healthcare System logo

Seattle Children's Healthcare System

Status

Completed

Conditions

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

Treatments

Procedure: RIPC
Procedure: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT01260259
CCTR-3953179

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 2 patient groups

Remote Ischemic Preconditioning (RIPC)
Experimental group
Treatment:
Procedure: RIPC
Control
Sham Comparator group
Treatment:
Procedure: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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