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Seattle Cardiorenal Remote Ischemic Preconditioning Trial (SCRIPT)

Primary Purpose

Congenital Heart Disease, Cardiopulmonary Bypass, Myocardial Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RIPC
Control
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Heart Disease focused on measuring Pediatric, Cardiac, Surgery, Cardiopulmonary, Bypass, Myocardial, Kidney, Lung, Injury

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Remote Ischemic Preconditioning (RIPC)

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 13, 2010
Last Updated
September 16, 2013
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01260259
Brief Title
Seattle Cardiorenal Remote Ischemic Preconditioning Trial
Acronym
SCRIPT
Official Title
Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Cardiopulmonary Bypass, Myocardial Injury, Acute Kidney Injury, Acute Lung Injury
Keywords
Pediatric, Cardiac, Surgery, Cardiopulmonary, Bypass, Myocardial, Kidney, Lung, Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote Ischemic Preconditioning (RIPC)
Arm Type
Experimental
Arm Title
Control
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
RIPC
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
In OR, after induction of general anesthesia and arterial line placement, a deflated tourniquet will be placed over the lower extremity for 40 minutes.
Primary Outcome Measure Information:
Title
Incidence of acute kidney injury (AKI)
Description
Serum creatinine (SCr) will be measured at baseline, then on post-operative days 1, 2, and 3.
Time Frame
72 hours
Title
Incidence of acute myocardial injury
Description
Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Incidence of acute lung injury
Description
Days on mechanical ventilation, readiness for extubation.
Time Frame
72 hours and duration of hospitalization
Title
Hospitalization
Description
Number of post-operative days in cardiac intensive care unit (CICU) and hospital.
Time Frame
Duration of post-operative hospitalization
Title
Mortality
Time Frame
Duration of hospitalization, 30 days post-op, and at last follow-up
Title
Biomarkers for AKI
Description
Serum and urine will be collected for biomarker discovery.
Time Frame
72 hours
Title
Inflammation
Description
Cytokines will be measured at baseline until 72 hours post-operative.
Time Frame
72 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine W Hsu, MD
Organizational Affiliation
Seattle Children's Hospital and University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuk Law, MD
Organizational Affiliation
Seattle Children's Hospital and University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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Seattle Cardiorenal Remote Ischemic Preconditioning Trial

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