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Completed

NCT Number: NCT01316497

Acute Kidney Injury in Children Operated for Congenital Heart Disease

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.

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Key information

Conditions

Acute Kidney Injury Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

remote ischemic preconditioning (RIPC)

Procedure

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

Procedure

The cuff was applied on the leg without inflation in the control group.

Primary outcomes

  1. Acute kidney injury

    Time frame: Up to 4 days

    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 outcomes

  1. Arterial blood pressure

    Time frame: Up to 3 days

    Incidence of postoperative low blood pressure (below the age-reference level)

  2. Inotropic Score (IS)

    Time frame: Up to 3 days

    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.

  3. Reoperation during hospital stay

    Time frame: 90 days

  4. Length of stay at the ICU

    Time frame: 90 days

  5. Length of hospital stay

    Time frame: 90 days

  6. Mortality

    Time frame: 90 days

    In-hospital mortality

  7. Level of cystatin C in plasma

    Time frame: Up to 4 days

  8. Level of Neutrophil Gelatinase-Associated Lipocalin in plasma and urine

    Time frame: Up to 4 days

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aase and Ejnar Danielsens Foundation
  • Direktør Kurt Bønnelycke and Hustru fru Grethe Bønnelyckes Foundation
  • Grosserer L.F. Foghts Foundation
  • Helen and Ejnar Bjørnows Foundation
  • Raimond and Dagmar Ringgård-Bohn's Foundation
  • Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
  • The Augustinus Foundation, Denmark.
  • The Dagmar Marshall Foundation

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 16, 2011
Registry last updated
Sep 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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