Clinical trial NCT01709227: Peritoneal Dialysis vs Furosemide for Acute Kidney Injury After Cardiopulmonary Bypass
Official title: Early Renal Replacement Therapy vs. Furosemide for Neonates With Oliguria After Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute kidney injury
AKI
cardiopulmonary bypass
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 73
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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.

Primary outcomes:
measure: Number of Participants With Negative Fluid Balance on Postop Day 1
timeFrame: Postop day 1
Secondary outcomes:
measure: Respiratory Support Administered
timeFrame: Duration of postoperative intubation (average time approximately- 1 week)
measure: NGAL Concentration
timeFrame: Pre-op, and postop (2hr, 6hr, 12hr, 24hr, 48hr)
measure: Duration of Cardiac ICU Stay
timeFrame: Average 2 weeks
measure: Duration of Hospital Stay
timeFrame: Average 4 weeks
measure: All Cause Mortality
timeFrame: duration of hospitalization (an average of 2 weeks)
measure: Renal/Electrolyte Abnormalities
timeFrame: Postop morning 1-5
measure: Doses of Potassium Chloride or Arginine Chloride Required
timeFrame: Postop day 0-5
measure: B-Natriuretic Peptide
timeFrame: At 24hours and 48 hours postoperative
measure: Modified Oxygenation Index
timeFrame: at 24 and 48 hours postoperative
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cinncinnati Children's Hospital Medical Center
name: David M Kwiatkowski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cinncinnati Children's Hospital Medical Center
name: Catherine D Krawczeski, MD
role: STUDY_DIRECTOR
affiliation: Cinncinnati Children's Hospital Medical Center
name: Stuart L Goldstein, MD
role: STUDY_DIRECTOR
References:
citation: 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.