Acute Kidney Injury in Children Operated for Congenital Heart Disease

Study Overview
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Brief Summary
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The purpose of this study was to investigate if repeated inflation of a blood pressure cuff applied around one leg causing mild ischemia (remote ischemic preconditioning) could protect children operated for congenital heart disease from developing acute kidney injury.

Detailed Description
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Remote ischemic preconditioning (RIPC) refers to an intervention of remote, brief ischemia which confers systemic protection against consequences of reperfusion injury in distant organs. RIPC has been shown to protect various organs during major surgeries. Our hypothesis was that RIPC could protect kidney function in children operated for complex congenital heart disease.

Official Title
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Acute Kidney Injury in Children Operated for Congenital Heart Disease

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Procedure: Remote ischemic preconditioning (RIPC)
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children admitted for surgery for congenital heart disease Exclusion Criteria: heart surgeries of low complexity such as closure of septal defects, aortico-pulmonary windows, establishment of glenn shunts, subaortic membrane resection, redirection of anomalous pulmonary veins, valvotomies, repair of pulmonary artery stenosis and surgeries without the use of extracorporeal circulation

Ages Eligible for Study
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Maximum Age: 15 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote ischemic preconditioning (RIPC)<br>See intervention description | Procedure: Remote ischemic preconditioning (RIPC)<br>* RIPC was performed by applying a blood pressure cuff around the child's leg. The cuff was inflated to 40 mmHg above the systolic pressure in 4 cycles of 5 minutes. Every cycle of ischemia was followed by 5 minutes of reperfusion. The first RIPC cycle started after anesthesia induction when invasive arterial blood pressure was monitored. Appropriate cuff size was used choosing between four sizes. For reproducibility RIPC was performed on the right leg with only a few exceptions, when the leg was used for invasive catheters.<br>|
| Placebo Comparator: Control<br> | Procedure: Control<br>* The cuff was applied on the leg without inflation in the control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury | Categorized according to the RIFLE criteria (22): R= risk= increased p-creatinine * 1.5 and/or urine output < 0.5 ml/kg/hour for 6 hours, I= injury= increased p-creatinine * 2 and/or urine output < 0.5 ml/kg/hour for 12 hours, F= failure= increased p-creatinine * 3 or p-creatinine ≥ 350 µmol/L in the setting of an acute increase of at least 44 µmol/L and/or urine output < 0.3 ml/kg/hour for 24 hours or anuria for 12 hours, L= complete loss of renal function for > 4 weeks (need for dialysis for longer than 4 weeks), E= end-stage renal disease (need for dialysis for longer than 3 months). | Up to 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial blood pressure | Incidence of postoperative low blood pressure (below the age-reference level) | Up to 3 days | 
| Inotropic Score (IS) | The highest postoperative daily dose (µg/kg//min) was used in the formula: IS = [(dopamine + dobutamine) × 1] + (milrinone × 10) + [(epinephrine + norepinephrine) × 100] to calculate the IS. | Up to 3 days | 
| Reoperation during hospital stay |  | 90 days | 
| Length of stay at the ICU |  | 90 days | 
| Length of hospital stay |  | 90 days | 
| Mortality | In-hospital mortality | 90 days | 
| Level of cystatin C in plasma |  | Up to 4 days | 
| Level of Neutrophil Gelatinase-Associated Lipocalin in plasma and urine |  | Up to 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute kidney injury, Ischemic preconditioning, Congenital heart defects, Cardiac surgical procedures, Infant, Child