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Study protocol and statistical analysis plan for the Early Peritoneal Dialysis in Infants after Cardiac Surgery
Siva P Namachivayam1,2,3,4, Warwick Butt1,2,4, Anneke C Grobler4,5
1Cardiac Intensive Care Unit, Royal Children's Hospital Melbourne, Melbourne, VIC, Australia.
Insights
This study protocol outlines the Early Peritoneal Dialysis in Infants after Cardiac Surgery (EPICS) trial. It investigates if early peritoneal dialysis (PD) improves outcomes for infants following cardiac surgery.
Area of Science:
- Pediatric Cardiac Surgery
- Intensive Care Medicine
- Nephrology
- Clinical Trials
Background:
- Peritoneal dialysis (PD) is a common therapy post-infant cardiac surgery.
- The efficacy of early PD initiation in the intensive care unit (ICU) remains uncertain.
- This protocol details the Early Peritoneal Dialysis in Infants after Cardiac Surgery (EPICS) trial.
Purpose of the Study:
- To describe the study protocol and statistical analysis plan for the EPICS trial.
- To evaluate the role of early PD in reducing major adverse outcomes in infants after cardiac surgery.
- To assess the impact of early PD on mechanical ventilation duration and ICU/hospital length of stay.
Main Methods:
- An open, randomized, two-group, single-center trial involving infants (≤180 days) undergoing cardiac surgery (Risk-Adjusted Classification for Congenital Heart Surgery categories 3-6) with cardiopulmonary bypass.
- Participants are randomized 1:1 to early PD (initiated soon after ICU admission for 24 hours) or a control group (no early PD).
- Primary outcome: composite of death, cardiac arrest, emergency chest reopening, or ECMO requirement within 90 days. Secondary outcomes include ventilation duration, ICU/hospital length of stay, and fluid balance.
Main Results:
- This section will report the findings of the EPICS trial once completed.
- The primary outcome is a composite of death, cardiac arrest, emergency chest reopening, and ECMO requirement within 90 days.
- Secondary outcomes include duration of mechanical ventilation, ICU and hospital length of stay, vasoactive-inotropic score, and fluid balance.
Conclusions:
- The EPICS trial will determine if early PD reduces major adverse events in infants post-cardiac surgery.
- The study will also assess the effect of early PD on key clinical outcomes like ventilation duration and length of stay.
- Results will inform clinical practice regarding PD use in critically ill infants after cardiac surgery.
Abstract:
Background: Peritoneal dialysis (PD) is a commonly used therapy after infant cardiac surgery. It is unclear whether early PD commenced soon after admission to an intensive care unit (ICU) after cardiac surgery results in better outcomes. Objective: To describe the study protocol and statistical analysis plan for the Early Peritoneal Dialysis in Infants after Cardiac Surgery (EPICS) trial. Design, setting, participants and intervention: The EPICS trial is an open, randomised, two-group, single-centre clinical study of infants ≤ 180 days of age who had cardiac surgery (in Risk-Adjusted Classification for Congenital Heart Surgery version 1 categories 3-6) with cardiopulmonary bypass. Participants will be randomly assigned 1:1 to early PD (treatment group) or no early PD (control group). Those assigned to the treatment group will begin receiving PD soon after ICU admission and continue receiving it for 24 hours. Those in the control group will not receive PD during the first 24 hours. Main outcome measures: The primary outcome is a composite measure consisting of one or more of death, cardiac arrest, emergency chest reopening, and requirement for extracorporeal membrane oxygenation (ECMO) within 90 days. The main secondary outcomes are duration of mechanical ventilation, ICU length of stay, hospital length of stay, vasoactive-inotropic score at 24 hours, and cumulative per cent fluid balance by end of Day 2. At Day 90, events such as mortality, requirement for ECMO, cardiac arrest, chest reopening, volume of packed red blood cell transfusion, postoperative infection, readmission to ICU, renal injury and brain injury will be assessed. Conclusions: The EPICS trial aims to evaluate the role of early PD after infant cardiac surgery in lowering the rate of a composite major outcome. In addition, it will test the effect of early PD on duration of mechanical ventilation, and on ICU and hospital length of stay. Trial registration: ACTRN12617001614381.
