Peritoneal Dialysis vs Furosemide for Acute Kidney Injury After Cardiopulmonary Bypass

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01709227
First received: September 20, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Acute Kidney Injury
Drug: Furosemide
Procedure: Peritoneal Dialysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Renal Replacement Therapy vs. Furosemide for Neonates With Oliguria After Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Fluid Balance [ Time Frame: Postop day 0-5 ] [ Designated as safety issue: No ]
    Difference of inputs and outputs, including urine output and PD drainage.


Secondary Outcome Measures:
  • Respiratory Support Administered [ Time Frame: Duration of intubation (average time approximately- 1 week) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • Duration of cardiac ICU stay [ Time Frame: Average 2 weeks ] [ Designated as safety issue: No ]
  • Duration of hospital stay [ Time Frame: Average 4 weeks ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: Duration of hospitalization (average time approximately- 4 weeks) ] [ Designated as safety issue: No ]
  • Renal/electrolyte abnormalities [ Time Frame: Postop morning 1-5 ] [ Designated as safety issue: No ]
  • Doses of Potassium Chloride or Arginine Chloride required [ Time Frame: Postop day 0-5 ] [ Designated as safety issue: No ]
  • B-Natriuretic Peptide [ Time Frame: Preop, postop day 1 and 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: October 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Furosemide
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.
Drug: Furosemide
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 Name: Lasix
Experimental: Peritoneal dialysis
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 will be directed by CICU attending and Nephrology service
Procedure: Peritoneal Dialysis
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 Name: PD

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709227

Contacts
Contact: David Kwiatkowski, MD 513-636-4432 dave.kwiatkowski@gmail.com

Locations
United States, Ohio
Cincinnati Childrens Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45223
Contact: David M Kwiatkowski, MD    513-636-4432    dave.kwiatkowski@gmail.com   
Principal Investigator: David M Kwiatkowski, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: David M Kwiatkowski, MD Cinncinnati Children's Hospital Medical Center
Study Director: Catherine D Krawczeski, MD Cinncinnati Children's Hospital Medical Center
Study Director: Stuart L Goldstein, MD Cinncinnati Children's Hospital Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01709227     History of Changes
Other Study ID Numbers: 2011-1730
Study First Received: September 20, 2012
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Acute kidney injury
AKI
cardiopulmonary bypass

Additional relevant MeSH terms:
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Furosemide
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014