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| Name | Class |
|---|---|
| Aase and Ejnar Danielsens Foundation | OTHER |
| The Augustinus Foundation, Denmark. | OTHER |
| Direktør Kurt Bønnelycke and Hustru fru Grethe Bønnelyckes Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote ischemic preconditioning (RIPC) | Experimental | See intervention description |
|
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic preconditioning (RIPC) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial blood pressure | Incidence of postoperative low blood pressure (below the age-reference level) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten MR Pedersen, MD | Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby | Study Director |
| Vibeke E Hjortdal, MD PhD DMSc | Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby | Principal Investigator |
| Hanne B Ravn, MD PhD | Department of Anesthesia and Intensive Care, Aarhus University Hospital, Skejby | Study Chair |
| Johan V Povlsen, MD | Department of Renal Medicine C, Aarhus University Hospital, Skejby | Study Chair |
| Michael R Schmidt, MD PhD | Aarhus University Hospital | Study Chair |
| Erland Erlandsen, MSc | Department of Clinical Biochemistry, Viborg Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17944638 | Background | 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. | |
| 16750696 | Background |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Helen and Ejnar Bjørnows Foundation |
| UNKNOWN |
| Raimond and Dagmar Ringgård-Bohn's Foundation | OTHER |
| Grosserer L.F. Foghts Foundation | UNKNOWN |
| Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation | OTHER |
| The Dagmar Marshall Foundation | OTHER |
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|
| Control | Procedure | The cuff was applied on the leg without inflation in the control group. |
|
| Up to 3 days |
| Reoperation during hospital stay | 90 days |
| Length of stay at the ICU | 90 days |
| Length of hospital stay | 90 days |
| Mortality | In-hospital mortality | 90 days |
| Level of cystatin C in plasma | Up to 4 days |
| Level of Neutrophil Gelatinase-Associated Lipocalin in plasma and urine | Up to 4 days |
| 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |