SCRIPT: Seattle Cardiorenal Remote Ischemic Preconditioning Trial

Sponsor

Seattle Children's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01260259

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease Cardiopulmonary Bypass Myocardial Injury Acute Kidney Injury Acute Lung Injury	Procedure: RIPC Procedure: Control	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seattle Children's Hospital	Seattle	Washington	United States	98105

Sponsors and Collaborators

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