A Hospital-Wide Open-Label Cluster Crossover Pragmatic Comparative Effectiveness Randomized Trial Comparing Normal...

Area of Science:

• Critical Care Medicine
• Clinical Trials
• Fluid Resuscitation

Background:

• Normal saline (NS) and Ringer's lactate (RL) are common crystalloids, but NS raises concerns for potential harm.
• Limited large-scale trials exist comparing these fluids in critically ill patients.
• Uncertainty remains regarding the clinical impact of NS versus RL on patient outcomes.

Purpose of the Study:

• To evaluate the effectiveness of hospital-wide policies favoring either NS or RL as the primary crystalloid fluid.
• The FLUID trial is a pragmatic, multicenter, cluster crossover randomized trial.
• To compare clinically important outcomes between NS and RL in hospitalized patients.

Main Methods:

• 16 hospitals in Ontario, Canada, will participate in a 2x2 cluster crossover design.
• Hospitals will preferentially stock either NS or RL for 12-week periods, then switch.
• All hospitalized adult and pediatric patients (N=144,000) will be included; primary outcome is 90-day death or readmission.

Main Results:

• The statistical analysis plan was prepared a priori.
• Data analysis will be based on the prepared plan upon receipt of trial data.
• Results will be derived from health administrative data, minimizing individual case reporting.

Conclusions:

• The FLUID trial protocol and statistical analysis plan are described.
• The study aims to provide crucial evidence on the comparative effectiveness of NS and RL.
• Findings will inform clinical practice regarding crystalloid fluid selection in hospitalized patients.