Peritoneal Dialysis vs Furosemide for Acute Kidney Injury After Cardiopulmonary Bypass

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Drug: Furosemide
* Procedure: Peritoneal Dialysis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Furosemide<br>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<br>* 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.<br>* Other names: Lasix;|
| Experimental: Peritoneal dialysis<br>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<br>* 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.<br>* Other names: PD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Support Administered | Duration of initial course of postoperative mechanical ventilation | 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 | Total days of initial postoperative stay in cardiac ICU | Average 2 weeks | 
| Duration of Hospital Stay | Total days of initial postoperative stay in hospital | Average 4 weeks | 
| All Cause Mortality | In-hospital mortality | duration of hospitalization (an average of 2 weeks) | 
| Renal/Electrolyte Abnormalities | Total sum of renal and electrolyte abnormalities over the first 5 postoperative days as defined in the protocol | Postop morning 1-5 | 
| Doses of Potassium Chloride or Arginine Chloride Required | Total doses of potassium chloride or arginine chloride given during the first five postoperative days. | Postop day 0-5 | 
| B-Natriuretic Peptide | BNP measured at 24 and 48 hours postoperatively | At 24hours and 48 hours postoperative | 
| Modified Oxygenation Index | Product of Mean airway pressure delivered by mechanical ventilation and FiO2 of administered oxygen | at 24 and 48 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute kidney injury, AKI, cardiopulmonary bypass