Peritoneal Dialysis vs Furosemide for Acute Kidney Injury After Cardiopulmonary Bypass

NCT01709227 | Completed Results DMC

• 1 other identifier: 2011-1730
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Acute kidney injury; AKI; cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

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

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

  Postop day 1

Secondary Outcomes (9)

• Respiratory Support Administered

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

• NGAL Concentration

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

• Duration of Cardiac ICU Stay

  Average 2 weeks

• Duration of Hospital Stay

  Average 4 weeks

• All Cause Mortality

  duration of hospitalization (an average of 2 weeks)

Study Arms (2)

Furosemide

EXPERIMENTAL

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

Peritoneal dialysis

EXPERIMENTAL

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

Interventions

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.

Also known as: Lasix

Furosemide

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.

Also known as: PD

Peritoneal dialysis

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age less than 6 months of age;
• Undergoing cardiothoracic surgery with CPB;
• Planned placement of PD catheter per institutional standard of care criteria.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45223, United States

Location

Related Publications (1)

• Kwiatkowski DM, Goldstein SL, Cooper DS, Nelson DP, Morales DL, Krawczeski CD. Peritoneal Dialysis vs Furosemide for Prevention of Fluid Overload in Infants After Cardiac Surgery: A Randomized Clinical Trial. JAMA Pediatr. 2017 Apr 1;171(4):357-364. doi: 10.1001/jamapediatrics.2016.4538.

  PMID: 28241247 DERIVED

Related Links

• Center for Acute Care Nephology at Cincinnati Childrens

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Furosemide; Peritoneal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Renal Dialysis; Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Results Point of Contact

• Title: David Kwiatkowski
• Organization: Stanford University

david.kwiatkowski@stanford.edu

650-721-3290

Study Officials

• David M Kwiatkowski, MD

  Cinncinnati Children's Hospital Medical Center

  PRINCIPAL INVESTIGATOR

• Catherine D Krawczeski, MD

  Cinncinnati Children's Hospital Medical Center

  STUDY DIRECTOR

• Stuart L Goldstein, MD

  Cinncinnati Children's Hospital Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: October 18, 2012
• Study Start: October 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 9, 2017
• Results First Posted: June 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)