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Acute Kidney Injury in Children Operated for Congenital Heart Disease

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Remote ischemic preconditioning (RIPC)
Control
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Acute kidney injury, Ischemic preconditioning, Congenital heart defects, Cardiac surgical procedures, Infant, Child

Eligibility Criteria

undefined - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Remote ischemic preconditioning (RIPC)

Control

Arm Description

See intervention description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Arterial blood pressure
Incidence of postoperative low blood pressure (below the age-reference level)
Inotropic Score (IS)
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
Length of stay at the ICU
Length of hospital stay
Mortality
In-hospital mortality
Level of cystatin C in plasma
Level of Neutrophil Gelatinase-Associated Lipocalin in plasma and urine

Full Information

First Posted
March 10, 2011
Last Updated
September 13, 2012
Sponsor
University of Aarhus
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, The Dagmar Marshall Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01316497
Brief Title
Acute Kidney Injury in Children Operated for Congenital Heart Disease
Official Title
Acute Kidney Injury in Children Operated for Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
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, The Dagmar Marshall Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Acute kidney injury, Ischemic preconditioning, Congenital heart defects, Cardiac surgical procedures, Infant, Child

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote ischemic preconditioning (RIPC)
Arm Type
Experimental
Arm Description
See intervention description
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning (RIPC)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
The cuff was applied on the leg without inflation in the control group.
Primary Outcome Measure Information:
Title
Acute kidney injury
Description
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).
Time Frame
Up to 4 days
Secondary Outcome Measure Information:
Title
Arterial blood pressure
Description
Incidence of postoperative low blood pressure (below the age-reference level)
Time Frame
Up to 3 days
Title
Inotropic Score (IS)
Description
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.
Time Frame
Up to 3 days
Title
Reoperation during hospital stay
Time Frame
90 days
Title
Length of stay at the ICU
Time Frame
90 days
Title
Length of hospital stay
Time Frame
90 days
Title
Mortality
Description
In-hospital mortality
Time Frame
90 days
Title
Level of cystatin C in plasma
Time Frame
Up to 4 days
Title
Level of Neutrophil Gelatinase-Associated Lipocalin in plasma and urine
Time Frame
Up to 4 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten MR Pedersen, MD
Organizational Affiliation
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vibeke E Hjortdal, MD PhD DMSc
Organizational Affiliation
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanne B Ravn, MD PhD
Organizational Affiliation
Department of Anesthesia and Intensive Care, Aarhus University Hospital, Skejby
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johan V Povlsen, MD
Organizational Affiliation
Department of Renal Medicine C, Aarhus University Hospital, Skejby
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael R Schmidt, MD PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Erland Erlandsen, MSc
Organizational Affiliation
Department of Clinical Biochemistry, Viborg Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
17944638
Citation
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.
Results Reference
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PubMed Identifier
16750696
Citation
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.
Results Reference
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Acute Kidney Injury in Children Operated for Congenital Heart Disease

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