Peritoneal Dialysis vs Furosemide for Acute Kidney Injury After Cardiopulmonary Bypass



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Hospital
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:Any
Updated:7/11/2015
Start Date:October 2011
End Date:June 2015
Contact:David Kwiatkowski, MD
Email:dave.kwiatkowski@gmail.com
Phone:513-636-4432

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Early Renal Replacement Therapy vs. Furosemide for Neonates With Oliguria After Cardiopulmonary Bypass

Acute kidney injury (AKI) after cardiopulmonary bypass (CPB) in infants is common and
associated with poor outcomes. Peritoneal dialysis (PD) and furosemide have been used to
attain negative fluid balance due to AKI induced oliguria, but have not been compared
prospectively. The investigators will prospectively compare outcomes of infants with
oliguria after CPB randomized to PD vs. furosemide with the hypothesis that infants
receiving PD have superior outcomes.

Background: Acute kidney injury (AKI) is a common postoperative complication after heart
surgery with cardiopulmonary bypass (CPB). Multiple studies have demonstrated that patients
with AKI have worse clinical outcomes, such as longer ventilation times and increased length
of stay, which is thought to be secondary to associated oliguria and subsequent fluid
overload. Studies suggest that early renal replacement therapy (RRT) via peritoneal dialysis
(PD) may prevent fluid overload and therefore be a superior management to diuretic (i.e.
furosemide) administration. However, there is no published evidence to suggest superiority
or laboratory data available to guide decision making.

Objective: Our primary objective is to determine if early institution of PD improves
clinical outcomes compared to administration of furosemide in post-operative cardiac infants
with acute kidney injury. We hypothesize that early initiation of PD will improve clinical
outcomes. We will determine if these clinical outcomes will be better among good responders
of furosemide compared to poor responders. We will determine if postoperative NGAL
concentrations are predictive of poor response to furosemide.

Design / Methods: The study will be a single-center randomized clinical trial among neonates
undergoing cardiac surgery with CPB with planned placement of a PD catheter due to risk of
AKI. If patients demonstrate oliguria within the first postoperative day, they will be
randomized to early PD or trial of furosemide. Clinical and laboratory data will be
collected and compared between groups.

Inclusion Criteria:

- Age less than 6 months of age;

- Undergoing cardiothoracic surgery with CPB;

- Planned placement of PD catheter per institutional standard of care criteria.

Exclusion Criteria:

- Pre-existing chronic kidney disease stage 3 or above (correlating with estimated
GFR<60 ml/min/m2, which will be calculated using routine preoperative serum
creatinine value using the modified Schwartz equation).

- Known history of allergy to furosemide.
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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