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. Identifier: NCT01260259
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : September 18, 2013
Information provided by (Responsible Party):
Christine Hsu, Seattle Children's Hospital

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : December 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. Incidence of acute lung injury [ Time Frame: 72 hours and duration of hospitalization ]
    Days on mechanical ventilation, readiness for extubation.

  2. Hospitalization [ Time Frame: Duration of post-operative hospitalization ]
    Number of post-operative days in cardiac intensive care unit (CICU) and hospital.

  3. Mortality [ Time Frame: Duration of hospitalization, 30 days post-op, and at last follow-up ]
  4. Biomarkers for AKI [ Time Frame: 72 hours ]
    Serum and urine will be collected for biomarker discovery.

  5. Inflammation [ Time Frame: 72 hours ]
    Cytokines will be measured at baseline until 72 hours post-operative.

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01260259

United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
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

Responsible Party: Christine Hsu, Principal Investigator, Seattle Children's Hospital Identifier: NCT01260259     History of Changes
Other Study ID Numbers: CCTR-3953179
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: September 2013

Keywords provided by Christine Hsu, Seattle Children's Hospital:

Additional relevant MeSH terms:
Wounds and Injuries
Heart Diseases
Acute Kidney Injury
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Respiration Disorders