JMIR Publications

ABSTRACT

Background:

Normal saline (NS) and Ringer’s lactate (RL) are the most common crystalloids given to hospitalised patients. Despite concern about possible harm associated with NS (e.g., hyperchloremic metabolic acidosis, impaired kidney function, and death), few large multi-centre randomised trials focused on critically ill patients have compared these fluids. Uncertainty exists about the effects of these fluids on clinically important outcomes across all hospitalised patients.

Objective:

The FLUID trial is a pragmatic, multicentre, 2x2 cluster crossover comparative effectiveness randomised trial which aims to evaluate the effectiveness of a hospital-wide policy which stocks either NS or RL as the main crystalloid fluid in 16 hospitals across Ontario, Canada.

Methods:

All hospitalised adult and pediatric patients (anticipated sample size 144,000 patients) with an incident admission to the hospital over the course of each study period will be included. Either NS or RL will be preferentially stocked throughout the hospital for 12 weeks before crossing to the alternate fluid for the subsequent 12 weeks. The primary outcome is a composite of death and hospital readmission within 90 days of hospitalisation. Secondary outcomes include death, hospital re-admission, dialysis, re-operation, post-operative re-intubation, length of hospital stay, emergency department visits, and discharge to a facility other than home. All outcomes will be obtained from health administrative data, eliminating the need for individual case reports. The primary analysis will use cluster-level summaries to estimate cluster-average treatment effects.

Results:

The statistical analysis plan has been prepared a priori in advance of receipt of the trial dataset from ICES and any analyses.

Conclusions:

We describe the protocol and statistical analysis plan for the evaluation of primary and secondary outcomes for the FLUID trial. Clinical Trial: ClinicalTrials.gov NCT04512950