Acute Kidney Injury in Children Operated for Congenital Heart Disease
NCT ID: NCT01316497
Last Updated: 2012-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2008-07-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Remote ischemic preconditioning (RIPC)
See intervention description
Remote ischemic preconditioning (RIPC)
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.
Control
Control
The cuff was applied on the leg without inflation in the control group.
Interventions
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Remote ischemic preconditioning (RIPC)
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.
Control
The cuff was applied on the leg without inflation in the control group.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
15 Years
ALL
No
Sponsors
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Aase and Ejnar Danielsens Foundation
OTHER
The Augustinus Foundation, Denmark.
OTHER
Direktør Kurt Bønnelycke and Hustru fru Grethe Bønnelyckes Foundation
UNKNOWN
Helen and Ejnar Bjørnows Foundation
UNKNOWN
Raimond and Dagmar Ringgård-Bohn's Foundation
OTHER
Grosserer L.F. Foghts Foundation
UNKNOWN
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
OTHER
The Dagmar Marshall Foundation
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Kirsten MR Pedersen, MD
Role: STUDY_DIRECTOR
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Vibeke E Hjortdal, MD PhD DMSc
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Hanne B Ravn, MD PhD
Role: STUDY_CHAIR
Department of Anesthesia and Intensive Care, Aarhus University Hospital, Skejby
Johan V Povlsen, MD
Role: STUDY_CHAIR
Department of Renal Medicine C, Aarhus University Hospital, Skejby
Michael R Schmidt, MD PhD
Role: STUDY_CHAIR
Aarhus University Hospital
Erland Erlandsen, MSc
Role: STUDY_CHAIR
Department of Clinical Biochemistry, Viborg Hospital
Locations
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Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Aarhus, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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20080052
Identifier Type: -
Identifier Source: org_study_id