Clinical Trial: Peritoneal Dialysis vs Furosemide for Acute Kidney Injury After Cardiopulmonary Bypass

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Children's Hospital Medical Center, Cincinnati

Current Primary Outcome: Fluid Balance [ Time Frame: Postop day 0-5 ]

Difference of inputs and outputs, including urine output and PD drainage.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Respiratory Support Administered [ Time Frame: Duration of intubation (average time approximately- 1 week) ]
    Product of Mean airway pressure and FiO2 of administered oxygen at 24 and 48 hours, and duration of intubation
  • NGAL Concentration [ Time Frame: Pre-op, and postop (2hr, 6hr, 12hr, 24hr, 48hr) ]
  • Duration of cardiac ICU stay [ Time Frame: Average 2 weeks ]
  • Duration of hospital stay [ Time Frame: Average 4 weeks ]
  • All cause mortality [ Time Frame: Duration of hospitalization (average time approximately- 4 weeks) ]
  • Renal/electrolyte abnormalities [ Time Frame: Postop morning 1-5 ]
  • Doses of Potassium Chloride or Arginine Chloride required [ Time Frame: Postop day 0-5 ]
  • B-Natriuretic Peptide [ Time Frame: Preop, postop day 1 and 2 ]


Original Secondary Outcome: Same as current

Information By: Children's Hospital Medical Center, Cincinnati

Dates:
Date Received: September 20, 2012
Date Started: October 2011
Date Completion:
Last Updated: June 24, 2015
Last Verified: June 2015