N/A
N=73
Peritoneal Dialysis vs Furosemide for Acute Kidney Injury After Cardiopulmonary Bypass
Acute Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT01709227 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants With Negative Fluid Balance on Postop Day 1 — 21; 29 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Furosemide (Drug); Peritoneal Dialysis (Procedure)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Negative Fluid Balance on Postop Day 1 |
21; 29 | — |
| SECONDARY Respiratory Support Administered |
4; 3 | — |
| SECONDARY NGAL Concentration |
— | — |
| SECONDARY Duration of Cardiac ICU Stay |
9; 7 | — |
| SECONDARY Duration of Hospital Stay |
15; 14 | — |
| SECONDARY All Cause Mortality |
3; 1 | — |
| SECONDARY Renal/Electrolyte Abnormalities |
6; 4 | — |
| SECONDARY Doses of Potassium Chloride or Arginine Chloride Required |
2; 1 | — |
| SECONDARY B-Natriuretic Peptide |
1334; 1168; 1110; 663 | — |
| SECONDARY Modified Oxygenation Index |
4; 4; 3.8; 2.8 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01709227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.