An interventional study of Remote ischemic preconditioning (RIPC) and Control in Acute Kidney Injury, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged Up to 15 Years. Per ClinicalTrials.gov, last updated 2012-09-14.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 105 is close to the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
See intervention description
Procedure: Remote ischemic preconditioning (RIPC)
Procedure: Control
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.
The cuff was applied on the leg without inflation in the control group.
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).
Time frame: Up to 4 days
Arterial blood pressure
Incidence of postoperative low blood pressure (below the age-reference level)
Time frame: Up to 3 days
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.
Time frame: Up to 3 days
Reoperation during hospital stay
Time frame: 90 days
Length of stay at the ICU
Time frame: 90 days
Length of hospital stay
Time frame: 90 days
Mortality
In-hospital mortality
Time frame: 90 days
Level of cystatin C in plasma
Time frame: Up to 4 days
Level of Neutrophil Gelatinase-Associated Lipocalin in plasma and urine
Time frame: Up to 4 days
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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University of Aarhus