Acute Kidney Injury in Children Operated for Congenital Heart Disease
1 other identifier
interventional
105
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 10, 2011
CompletedFirst Posted
Study publicly available on registry
March 16, 2011
CompletedSeptember 14, 2012
September 1, 2012
2.4 years
March 10, 2011
September 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Arterial blood pressure
Up to 3 days
Inotropic Score (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
- +3 more secondary outcomes
Study Arms (2)
Remote ischemic preconditioning (RIPC)
EXPERIMENTALSee intervention description
Control
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Children admitted for surgery for congenital heart disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aase and Ejnar Danielsens Foundationcollaborator
- The Augustinus Foundation, Denmark.collaborator
- Direktør Kurt Bønnelycke and Hustru fru Grethe Bønnelyckes Foundationcollaborator
- Helen and Ejnar Bjørnows Foundationcollaborator
- Raimond and Dagmar Ringgård-Bohn's Foundationcollaborator
- Grosserer L.F. Foghts Foundationcollaborator
- Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundationcollaborator
- The Dagmar Marshall Foundationcollaborator
Study Sites (1)
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Aarhus, 8200, Denmark
Related Publications (2)
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.
PMID: 17944638BACKGROUNDCheung 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.
PMID: 16750696BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kirsten MR Pedersen, MD
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
- PRINCIPAL INVESTIGATOR
Vibeke E Hjortdal, MD PhD DMSc
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
- STUDY CHAIR
Hanne B Ravn, MD PhD
Department of Anesthesia and Intensive Care, Aarhus University Hospital, Skejby
- STUDY CHAIR
Johan V Povlsen, MD
Department of Renal Medicine C, Aarhus University Hospital, Skejby
- STUDY CHAIR
Michael R Schmidt, MD PhD
Aarhus University Hospital
- STUDY CHAIR
Erland Erlandsen, MSc
Department of Clinical Biochemistry, Viborg Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2011
First Posted
March 16, 2011
Study Start
July 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
September 14, 2012
Record last verified: 2012-09