Acute Kidney Injury in Children Operated for Congenital Heart Disease

Acute Kidney Injury Clinical Trial

Official title:

Acute Kidney Injury in Children Operated for Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316497
• Other study ID #: 20080052
• Status: Completed
• Phase: N/A
• First received: March 10, 2011
• Last updated: September 13, 2012
• Start date: July 2008
• Est. completion date: December 2010

Study information

• Verified date: September 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Heart Defects, Congenital
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby	Aarhus

Sponsors (9)

Lead Sponsor	Collaborator
University of Aarhus	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

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. Epub 2006 May 15. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Arterial blood pressure	Incidence of postoperative low blood pressure (below the age-reference level)	Up to 3 days	No
Secondary	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.	Up to 3 days	No
Secondary	Reoperation during hospital stay		90 days	No
Secondary	Length of stay at the ICU		90 days	No
Secondary	Length of hospital stay		90 days	No
Secondary	Mortality	In-hospital mortality	90 days	No
Secondary	Level of cystatin C in plasma		Up to 4 days	No
Secondary	Level of Neutrophil Gelatinase-Associated Lipocalin in plasma and urine		Up to 4 days	No