Acute Kidney Injury in Children Operated for Congenital Heart Disease

This study has been completed.
Sponsor:
Collaborators:
Aase and Ejnar Danielsens Foundation
The Augustinus Foundation, Denmark.
Direktør Kurt Bønnelycke and Hustru fru Grethe Bønnelyckes Foundation
Helen and Ejnar Bjørnows Foundation
Raimond and Dagmar Ringgård-Bohn's Foundation
Grosserer L.F. Foghts Foundation
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
Dagmar Marshall´s Foundation
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01316497
First received: March 10, 2011
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Acute Kidney Injury
Procedure: Remote ischemic preconditioning (RIPC)
Procedure: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Kidney Injury in Children Operated for Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Acute kidney injury [ Time Frame: Up to 4 days ] [ Designated as safety issue: No ]
    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:
  • Arterial blood pressure [ Time Frame: Up to 3 days ] [ Designated as safety issue: No ]
    Incidence of postoperative low blood pressure (below the age-reference level)

  • Inotropic Score (IS) [ Time Frame: Up to 3 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Length of stay at the ICU [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    In-hospital mortality

  • Level of cystatin C in plasma [ Time Frame: Up to 4 days ] [ Designated as safety issue: No ]
  • Level of Neutrophil Gelatinase-Associated Lipocalin in plasma and urine [ Time Frame: Up to 4 days ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: July 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remote ischemic preconditioning (RIPC)
See intervention description
Procedure: 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.
Placebo Comparator: Control Procedure: Control
The cuff was applied on the leg without inflation in the control group.

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

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01316497

Locations
Denmark
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aase and Ejnar Danielsens Foundation
The Augustinus Foundation, Denmark.
Direktør Kurt Bønnelycke and Hustru fru Grethe Bønnelyckes Foundation
Helen and Ejnar Bjørnows Foundation
Raimond and Dagmar Ringgård-Bohn's Foundation
Grosserer L.F. Foghts Foundation
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
Dagmar Marshall´s Foundation
Investigators
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 Department of Cardiology, Aarhus University Hospital, Skejby
Study Chair: Erland Erlandsen, MSc Department of Clinical Biochemistry, Viborg Hospital
  More Information

Publications:
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01316497     History of Changes
Other Study ID Numbers: 20080052
Study First Received: March 10, 2011
Last Updated: September 13, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Acute kidney injury
Ischemic preconditioning
Congenital heart defects
Cardiac surgical procedures
Infant
Child

Additional relevant MeSH terms:
Heart Diseases
Acute Kidney Injury
Heart Defects, Congenital
Wounds and Injuries
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 11, 2014