Seattle Cardiorenal Remote Ischemic Preconditioning Trial (SCRIPT)

Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Injury; Acute Kidney Injury; Cardiopulmonary Bypass; Acute Lung Injury; Congenital Heart Disease
• Intervention / Treatment: Procedure: RIPC; Procedure: Control

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control	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.
Experimental: Remote Ischemic Preconditioning (RIPC)	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Investigators: Principal Investigator: Christine W Hsu, MD, Seattle Children's Hospital and University of Washington; Principal Investigator: Yuk Law, MD, Seattle Children's Hospital and University of Washington

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: December 13, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimate): December 15, 2010

Study Record Updates

• Last Update Posted (Estimate): September 18, 2013
• Last Update Submitted That Met QC Criteria: September 16, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Surgery; Pediatric; Lung; Kidney; Cardiac; Injury; Myocardial; Bypass; Cardiopulmonary
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Kidney Diseases; Urologic Diseases; Congenital Abnormalities; Renal Insufficiency; Cardiovascular Abnormalities; Thoracic Injuries; Heart Diseases; Wounds and Injuries; Acute Kidney Injury; Heart Defects, Congenital; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: CCTR-3953179