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.
ABSTRACT
Objectives: To investigate the precision of weight measurements in critically ill infants in a paediatric intensive care unit (PICU). Design: Prospective cohort study. Setting: Royal Children's Hospital PICU. Participants: Mechanically ventilated infants admitted to the Royal Children's Hospital PICU between September 2020 and February 2021. Main outcome measures: Mean percentage difference and agreement of consecutive weight measurements. Results: Thirty infants were enrolled, of which 17 were receiving post-surgical care for congenital heart disease and four were receiving extracorporeal membrane oxygenation (ECMO). The median age was 13 days (interquartile range [IQR], 3.1-52.4 days). The mean difference in weight was 1.3% (standard deviation [SD], 1.0%), and the test-retest agreement intraclass correlation was 0.99 (95% CI, 0.99-0.99; P < 0.01). The percentage difference between measurements was ≤ 2.5% in 26/30 (87%) children, and the range was < 0.1% to 3.6%. In 26 children not receiving ECMO, the mean difference in weight was 1.1% (SD, 1.0%). There were no complications. Conclusions: Weighing mechanically ventilated, critically ill infants in intensive care can be performed safely, with a mean difference between consecutive weights of 1.3%, making it a potentially useful additional measure of fluid accumulation.
