A randomised, controlled, feasibility trial comparing vasopressors infused via peripheral cannula versus central venous access for critically ill adults: The VIPCA trial.

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).