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Acute Kidney Injury in Children Operated for Congenital Heart Disease

University of Aarhus logo

University of Aarhus

Status

Completed

Conditions

Acute Kidney Injury

Treatments

Procedure: Control
Procedure: Remote ischemic preconditioning (RIPC)

Study type

Interventional

Funder types

Other

Identifiers

NCT01316497
20080052

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

All

Ages

Under 15 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

105 participants in 2 patient groups, including a placebo group

Remote ischemic preconditioning (RIPC)
Experimental group
Description:
See intervention description
Treatment:
Procedure: Remote ischemic preconditioning (RIPC)
Control
Placebo Comparator group
Treatment:
Procedure: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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