Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Heart Disease
- Sponsor
- Seattle Children's Hospital
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Incidence of acute kidney injury (AKI)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
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.
Investigators
Christine Hsu
Principal Investigator
Seattle Children's Hospital
Eligibility 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Biomarkers for AKI(72 hours)
- Incidence of acute lung injury(72 hours and duration of hospitalization)
- Mortality(Duration of hospitalization, 30 days post-op, and at last follow-up)
- Hospitalization(Duration of post-operative hospitalization)
- Inflammation(72 hours)