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Seattle Cardiorenal Remote Ischemic Preconditioning Trial (SCRIPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christine Hsu, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01260259
First received: December 13, 2010
Last updated: September 16, 2013
Last verified: September 2013

December 13, 2010
September 16, 2013
December 2010
August 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01260259 on ClinicalTrials.gov Archive Site
  • Incidence of acute lung injury [ Time Frame: 72 hours and duration of hospitalization ] [ 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, 30 days post-op, and at last follow-up ] [ 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.
  • 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.
Not Provided
Not Provided
 
Seattle Cardiorenal Remote Ischemic Preconditioning Trial
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Congenital Heart Disease
  • Cardiopulmonary Bypass
  • Myocardial Injury
  • Acute Kidney Injury
  • Acute Lung Injury
  • 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.
  • 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)
    Intervention: Procedure: RIPC
  • Sham Comparator: Control
    Intervention: Procedure: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
August 2013
August 2013   (final data collection date for primary outcome measure)

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

Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01260259
CCTR-3953179
Yes
Christine Hsu, Seattle Children's Hospital
Seattle Children's Hospital
Not Provided
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
Seattle Children's Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP