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
  Purpose

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 Intervention
Congenital Heart Disease
Cardiopulmonary Bypass
Myocardial Injury
Acute Kidney Injury
Acute Lung Injury
Procedure: RIPC
Procedure: Control

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 90
Study Start Date: December 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260259

Locations
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Christine Hsu, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01260259     History of Changes
Other Study ID Numbers: CCTR-3953179
Study First Received: December 13, 2010
Last Updated: September 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
Pediatric
Cardiac
Surgery
Cardiopulmonary
Bypass
Myocardial
Kidney
Lung
Injury

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

ClinicalTrials.gov processed this record on October 23, 2014