Seattle Cardiorenal Remote Ischemic Preconditioning Trial (SCRIPT)
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.
Congenital Heart Disease
Acute Kidney Injury
Acute Lung Injury
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery|
- Incidence of acute kidney injury (AKI) [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Days on mechanical ventilation, readiness for extubation.
- Hospitalization [ Time Frame: Duration of post-operative hospitalization ] [ Designated as safety issue: Yes ]Number of post-operative days in cardiac intensive care unit (CICU) and hospital.
- Mortality [ Time Frame: Duration of hospitalization ] [ Designated as safety issue: Yes ]
- Biomarkers for AKI [ Time Frame: 72 hours ] [ Designated as safety issue: No ]Serum and urine will be collected for biomarker discovery.
- Inflammation [ Time Frame: 72 hours ] [ Designated as safety issue: No ]Cytokines will be measured at baseline until 72 hours post-operative.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|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.
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.
|Contact: Christine W Hsu, MDemail@example.com|
|Contact: Yuk Law, MDfirstname.lastname@example.org|
|United States, Washington|
|Seattle Children's Hospital||Recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Christine W Hsu, MD, MS 206-543-2346 email@example.com|
|Contact: Yuk Law, MD 206-987-5607 firstname.lastname@example.org|
|Principal Investigator: Christine W Hsu, MD|
|Principal Investigator: Yuk Law, MD|
|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|