Acute Kidney Injury in Children Operated for Congenital Heart Disease

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.

Conditions

• Acute Kidney Injury

Interventions

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.

PROCEDURE

Control

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

Sponsors & Collaborators

• Aase and Ejnar Danielsens Foundation

  collaborator OTHER

• The Augustinus Foundation, Denmark.

  collaborator OTHER

• Direktør Kurt Bønnelycke and Hustru fru Grethe Bønnelyckes Foundation

  collaborator UNKNOWN

• Helen and Ejnar Bjørnows Foundation

  collaborator UNKNOWN

• Raimond and Dagmar Ringgård-Bohn's Foundation

  collaborator OTHER

• Grosserer L.F. Foghts Foundation

  collaborator UNKNOWN

• Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation

  collaborator OTHER

• The Dagmar Marshall Foundation

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Kirsten MR Pedersen, MD · Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby

• Vibeke E Hjortdal, MD PhD DMSc · Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby

• Hanne B Ravn, MD PhD · Department of Anesthesia and Intensive Care, Aarhus University Hospital, Skejby

• Johan V Povlsen, MD · Department of Renal Medicine C, Aarhus University Hospital, Skejby

• Michael R Schmidt, MD PhD · Aarhus University Hospital

• Erland Erlandsen, MSc · Department of Clinical Biochemistry, Viborg Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2010-12-31

Completion

2010-12-31

Countries

• Denmark

Study Locations