Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Renal Impairment / Chronic Kidney Disease, Cardiology, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | Any - 21 |
| Updated: | 12/10/2017 |
| Start Date: | September 2013 |
| End Date: | July 22, 2017 |
Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery: A Randomized Clinical Trial
The proposed study will investigate the effect of sodium bicarbonate on the prevention of
acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The
investigators hypothesize that the occurrence of acute kidney injury will be less in children
treated with sodium bicarbonate in the perioperative period when compared to placebo. The
specific aims of this proposal are as follows:
1. To institute a prospective, randomized, double-blinded, placebo-controlled trial in
pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate
on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether
treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid
balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To
determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.
acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The
investigators hypothesize that the occurrence of acute kidney injury will be less in children
treated with sodium bicarbonate in the perioperative period when compared to placebo. The
specific aims of this proposal are as follows:
1. To institute a prospective, randomized, double-blinded, placebo-controlled trial in
pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate
on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether
treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid
balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To
determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.
Inclusion Criteria:
1. Subjects age ≤18 years
2. Subjects scheduled for cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
1. Subjects with abnormal creatinine clearance (<90 ml/min/1.7m2) as measured by the
Schwartz formula
2. Subjects with known cystic kidney disease or posterior ureteral valves (subjects with
solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be
excluded if renal function is preserved)
3. Subjects with known metabolic disorder
4. Premature infants born <30 weeks gestation and <30 days old due to risk of
intraventricular hemorrhage
Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane
oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the
study.
We found this trial at
1
site
New Hyde Park, New York 11040
Principal Investigator: James Schneider, MD
Phone: 718-470-3330
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