Clinical trial NCT01316497: Acute Kidney Injury in Children Operated for Congenital Heart Disease
Official title: Acute Kidney Injury in Children Operated for Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute kidney injury
Ischemic preconditioning
Congenital heart defects
Cardiac surgical procedures
Infant
Child
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aase and Ejnar Danielsens Foundation
name: The Augustinus Foundation, Denmark.
name: Direktør Kurt Bønnelycke and Hustru fru Grethe Bønnelyckes Foundation
name: Helen and Ejnar Bjørnows Foundation
name: Raimond and Dagmar Ringgård-Bohn's Foundation
name: Grosserer L.F. Foghts Foundation
name: Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
name: The Dagmar Marshall Foundation
First posted: 2011-03-16
Enrollment: 105
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute kidney injury
timeFrame: Up to 4 days
Secondary outcomes:
measure: Arterial blood pressure
timeFrame: Up to 3 days
measure: Inotropic Score (IS)
timeFrame: Up to 3 days
measure: Reoperation during hospital stay
timeFrame: 90 days
measure: Length of stay at the ICU
timeFrame: 90 days
measure: Length of hospital stay
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
measure: Level of cystatin C in plasma
timeFrame: Up to 4 days
measure: Level of Neutrophil Gelatinase-Associated Lipocalin in plasma and urine
timeFrame: Up to 4 days
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Study officials:
affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
name: Kirsten MR Pedersen, MD
role: STUDY_DIRECTOR
affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
name: Vibeke E Hjortdal, MD PhD DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesia and Intensive Care, Aarhus University Hospital, Skejby
name: Hanne B Ravn, MD PhD
role: STUDY_CHAIR
affiliation: Department of Renal Medicine C, Aarhus University Hospital, Skejby
name: Johan V Povlsen, MD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Michael R Schmidt, MD PhD
role: STUDY_CHAIR
affiliation: Department of Clinical Biochemistry, Viborg Hospital
name: Erland Erlandsen, MSc
role: STUDY_CHAIR
References:
citation: Pedersen KR, Povlsen JV, Christensen S, Pedersen J, Hjortholm K, Larsen SH, Hjortdal VE. Risk factors for acute renal failure requiring dialysis after surgery for congenital heart disease in children. Acta Anaesthesiol Scand. 2007 Nov;51(10):1344-9. doi: 10.1111/j.1399-6576.2007.01379.x.
citation: Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.