Statistical analysis plan for the SQUEEZE trial: A trial to determine whether septic shock reversal is quicker in pediatric patients randomized to an early goal-directed fluid-sparing strategy vs. usual care (SQUEEZE).

ABSTRACT:

Background

The SQUEEZE trial is a multicentred randomized controlled trial which seeks to determine the optimal approach to fluid resuscitation in paediatric septic shock. SQUEEZE also includes a nested translational study, SQUEEZE-D, investigating the value of plasma cell-free DNA for prediction of clinical outcomes.

Objective

To present a pre-specified statistical analysis plan (SAP) for the SQUEEZE trial prior to finalizing the trial data set and prior to commencing data analysis.

Design

SQUEEZE is a pragmatic, two-arm, open-label, prospective multicentre randomized controlled trial.

Setting

Canadian paediatric tertiary care centres.

Participants

Paediatric patients with suspected sepsis and persistent signs of shock in need of ongoing resuscitation.

SUBMITTER: Parker MJ 

PROVIDER: S-EPMC11282343 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature