Abstract
OBJECTIVE: To determine the feasibility of conducting a definitive randomised trial to determine whether, in critically ill patients requiring intensive care unit admission, early CVC insertion compared with late CVC insertion leads to increased days-alive-and-out-of-hospital at 30 days (DAH-30) post-treatment. DESIGN SETTINGS AND PARTICIPANTS: We conducted a single-centre, parallel-group, feasibility randomised controlled trial with critically ill patients receiving vasopressor infusions randomised in a 1:1 ratio to receive early CVC insertion (within 4 h) or late CVC insertion (after 12 h). All patients received vasopressor infusions via a peripheral intravenous cannula (PIVC) while awaiting CVC insertion. The primary clinical outcome was DAH-30 and the primary feasibility outcome was assessed by evaluating protocol adherence, rates of recruitment, randomisation of eligible patients, retention, follow-up and missing data. RESULTS: We enrolled 40 patients, 20 patients per group between January 2023 and May 2024. Protocol adherence was significantly lower in the early CVC group (55 %) compared to the late CVC group (100 %, p < 0.001). The early CVC group had a median time to CVC insertion of 3.3 h (interquartile range (IQR) 1.2-3.7 h), within the 4-h target. The early and late CVC groups had a median (IQR) of 13.5 (0.0-23.5) and 19.0 (5.0-23.0) DAH-30 respectively (P = 0.18). PIVC complications were similar between the two groups with no severe complications. There were no complications among the 18 CVCs inserted during the trial. CONCLUSIONS: Protocol adherence in the early CVC was much lower than the late CVC. Some protocol modifications will be required to enable the conduct of a larger-scale definitive trial. TRIAL REGISTRATION: ACTRN12621000721808 (Australia New Zealand Clinical Trials Registry).