Seattle Cardiorenal Remote Ischemic Preconditioning Trial (SCRIPT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01260259|
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : September 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease Cardiopulmonary Bypass Myocardial Injury Acute Kidney Injury Acute Lung Injury||Procedure: RIPC Procedure: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
|Experimental: Remote Ischemic Preconditioning (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||
In OR, after induction of general anesthesia and arterial line placement, a deflated tourniquet will be placed over the lower extremity for 40 minutes.
- Incidence of acute kidney injury (AKI) [ Time Frame: 72 hours ]Serum creatinine (SCr) will be measured at baseline, then on post-operative days 1, 2, and 3.
- Incidence of acute myocardial injury [ Time Frame: 48 hours ]Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative.
- Incidence of acute lung injury [ Time Frame: 72 hours and duration of hospitalization ]Days on mechanical ventilation, readiness for extubation.
- Hospitalization [ Time Frame: Duration of post-operative hospitalization ]Number of post-operative days in cardiac intensive care unit (CICU) and hospital.
- Mortality [ Time Frame: Duration of hospitalization, 30 days post-op, and at last follow-up ]
- Biomarkers for AKI [ Time Frame: 72 hours ]Serum and urine will be collected for biomarker discovery.
- Inflammation [ Time Frame: 72 hours ]Cytokines will be measured at baseline until 72 hours post-operative.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260259
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|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|