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Completed

NCT Number: NCT01709227

Peritoneal Dialysis vs Furosemide for Acute Kidney Injury 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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45223, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Furosemide

Drug

Patients randomized to the furosemide arm will be given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output <1 ml/kg/hr over 16 hours after the first dose of Lasix will be considered poor responders. These patients may be started on PD if clinically indicated. Those who show good response (urine output >1 ml/kg/hr over subsequent 16 hours) will continue furosemide as needed to augment urine output. If they subsequently develop oliguria or fluid overload unresponsive to diuretic therapy, these patients may later be started on PD at discretion of CICU attending with consultation of nephrology service.

Other names: Lasix

Peritoneal dialysis

Procedure

Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management and discontinuation will be directed by CICU attending and Nephrology service.

Other names: PD

Primary outcomes

  1. Number of Participants With Negative Fluid Balance on Postop Day 1

    Time frame: Postop day 1

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

Secondary outcomes

  1. Respiratory Support Administered

    Time frame: Duration of postoperative intubation (average time approximately- 1 week)

    Duration of initial course of postoperative mechanical ventilation

  2. NGAL Concentration

    Time frame: Pre-op, and postop (2hr, 6hr, 12hr, 24hr, 48hr)

  3. Duration of Cardiac ICU Stay

    Time frame: Average 2 weeks

    Total days of initial postoperative stay in cardiac ICU

  4. Duration of Hospital Stay

    Time frame: Average 4 weeks

    Total days of initial postoperative stay in hospital

  5. All Cause Mortality

    Time frame: duration of hospitalization (an average of 2 weeks)

    In-hospital mortality

  6. Renal/Electrolyte Abnormalities

    Time frame: Postop morning 1-5

    Total sum of renal and electrolyte abnormalities over the first 5 postoperative days as defined in the protocol

  7. Doses of Potassium Chloride or Arginine Chloride Required

    Time frame: Postop day 0-5

    Total doses of potassium chloride or arginine chloride given during the first five postoperative days.

  8. B-Natriuretic Peptide

    Time frame: At 24hours and 48 hours postoperative

    BNP measured at 24 and 48 hours postoperatively

  9. Modified Oxygenation Index

    Time frame: at 24 and 48 hours postoperative

    Product of Mean airway pressure delivered by mechanical ventilation and FiO2 of administered oxygen

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 18, 2012
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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