Acute Kidney Injury
Conditions
Keywords
Acute kidney injury, Ischemic preconditioning, Congenital heart defects, Cardiac surgical procedures, Infant, Child
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.
Interventions
PROCEDURERemote 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.
PROCEDUREControl
The cuff was applied on the leg without inflation in the control group.
Sponsors
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
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury | 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
| Measure | Time frame | Description |
|---|---|---|
| Inotropic Score (IS) | 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. |
| Reoperation during hospital stay | 90 days | — |
| Length of stay at the ICU | 90 days | — |
| Arterial blood pressure | Up to 3 days | Incidence of postoperative low blood pressure (below the age-reference level) |
| Mortality | 90 days | In-hospital mortality |
| Level of cystatin C in plasma | Up to 4 days | — |
| Level of Neutrophil Gelatinase-Associated Lipocalin in plasma and urine | Up to 4 days | — |
| Length of hospital stay | 90 days | — |
Countries
Denmark
Outcome results
None listed