Seattle Cardiorenal Remote Ischemic Preconditioning Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery

Conditions
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Congenital Heart Disease, Cardiopulmonary Bypass, Myocardial Injury, Acute Kidney Injury, Acute Lung Injury

Intervention / Treatment
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* Procedure: RIPC
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Ischemic Preconditioning (RIPC)<br> | Procedure: RIPC<br>* 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.<br>|
| Sham Comparator: Control<br> | Procedure: Control<br>* In OR, after induction of general anesthesia and arterial line placement, a deflated tourniquet will be placed over the lower extremity for 40 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute kidney injury (AKI) | Serum creatinine (SCr) will be measured at baseline, then on post-operative days 1, 2, and 3. | 72 hours | 
| Incidence of acute myocardial injury | Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute lung injury | Days on mechanical ventilation, readiness for extubation. | 72 hours and duration of hospitalization | 
| Hospitalization | Number of post-operative days in cardiac intensive care unit (CICU) and hospital. | Duration of post-operative hospitalization | 
| Mortality |  | Duration of hospitalization, 30 days post-op, and at last follow-up | 
| Biomarkers for AKI | Serum and urine will be collected for biomarker discovery. | 72 hours | 
| Inflammation | Cytokines will be measured at baseline until 72 hours post-operative. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Cardiac, Surgery, Cardiopulmonary, Bypass, Myocardial, Kidney, Lung, Injury