A recent clinical trial conducted by researchers at The Ottawa Hospital and the University of Ottawa, which was published in the New England Journal of Medicine, has shed light on a novel and efficient method for comparing standard treatments. The FLUID trial focused on comparing two commonly used intravenous fluids in hospitalized patients: normal saline and Ringer’s lactate. These fluids are widely utilized in hospitals, with no clear evidence favoring one over the other.
Unlike traditional trials that randomly assign patients to receive one fluid or the other, the FLUID trial took a unique approach by randomly assigning entire hospitals to use one fluid for three months before switching to the other. This method allowed the researchers to gather data from over 43,000 patients in seven Ontario hospitals by accessing clinical data from health administrative sources at ICES, without the need for individual patient recruitment.
While the trial demonstrated the value of this hospital-wide approach for comparing treatments, it had to be halted prematurely due to the COVID-19 pandemic, preventing the researchers from detecting subtle differences in outcomes between patients who received the different fluids. Despite this setback, Dr. Lauralyn McIntyre, the lead researcher of the trial, highlighted the cost-effectiveness of this approach, estimating that it costs less than $10 to enroll a single patient compared to traditional trials costing over $1,000 per patient.
The Ottawa Hospital’s Ottawa Methods Center, led by Dr. Monica Taljaard, played a pivotal role in designing this cluster-randomized trial. Dr. Taljaard emphasized the potential for other researchers to leverage this experience to efficiently address critical questions in healthcare. Dr. McIntyre also commended the collaborative effort of hospital staff and other participating hospitals in supporting the research.
Approved by the Ottawa Health Science Network Research Ethics Board, this trial underscores the importance of innovative research methodologies in advancing patient care. For more information on the FLUID trial, readers can refer to the article published in the New England Journal of Medicine.
The findings of this trial exemplify the power of collaborative research efforts in healthcare and the potential for transformative approaches to clinical trials. As the healthcare landscape continues to evolve, initiatives like the FLUID trial pave the way for more efficient and cost-effective research methods that benefit patients and the healthcare system as a whole.
