Acute Kidney Injury in Children Operated for Congenital Heart Disease

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Procedure: Remote ischemic preconditioning (RIPC); Procedure: Control

• Registration Number: NCT01316497
• Lead Sponsor: University of Aarhus

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-03-10
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-16
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-13
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Children admitted for surgery for congenital heart disease

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote ischemic preconditioning (RIPC)	Remote ischemic preconditioning (RIPC)	See intervention description
Control	Control	-

Primary Outcome Measures

Name	Time	Method
Acute kidney injury	Up to 4 days	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).

Secondary Outcome Measures

Name	Time	Method
Arterial blood pressure	Up to 3 days	Incidence of postoperative low blood pressure (below the age-reference level)
Inotropic Score (IS)	Up to 3 days	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.
Reoperation during hospital stay	90 days
Length of stay at the ICU	90 days
Length of hospital stay	90 days
Mortality	90 days	In-hospital mortality
Level of cystatin C in plasma	Up to 4 days
Level of Neutrophil Gelatinase-Associated Lipocalin in plasma and urine	Up to 4 days

Trial Locations

Locations (1)

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark