Crystalloid FLUID Choices for Resuscitation of Hospital Patients (FLUID)
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|ClinicalTrials.gov Identifier: NCT02721485|
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : October 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fluid Therapy||Other: Ringer's Lactate Other: Normal Saline||Not Applicable|
Other than the administration of oxygen, crystalloid resuscitation fluids are the most common intervention administered to the majority of hospitalized patients. These fluids may be used as a life saving measure to re-establish hemodynamic stability, for rehydration, and to replace losses and maintain intravascular volume in the surgical setting. In the province of Ontario alone, approximately 1 million patients per year will receive one or both of these resuscitation fluids during their hospital admission. The two most common usual care resuscitation crystalloid fluids are Normal Saline and Ringer's Lactate and until recently there was no evidence to suggest that one crystalloid fluid was clinically superior to the other. However, the safety of Normal Saline is now being questioned due to its high chloride content and its association with the development of hyperchloremic metabolic acidosis. Studies in healthy volunteers and observational studies in the critically ill and surgical patient populations have associated saline with an increased risk of acute renal injury and requirement for dialysis, post-operative infections, death and increased resource and blood transfusion use. The evidence base is currently weak given that the majority of studies are observational and suffer from methodological weaknesses including confounding by indication, selection bias, and inability to disentangle the effects of a specific fluid due to interaction of co-interventions administered. As such, several authors and editorials have called for adequately powered randomized controlled trials with clinically relevant outcomes to determine if Ringer's Lactate is indeed superior to Normal Saline for resuscitation.
Given their widespread use, small differences in clinical outcomes between crystalloid resuscitation fluids are highly relevant. Furthermore, small absolute differences in important clinical outcomes translate into significant savings to hospitals and the health care system. To illustrate, if death and hospital re-admissions were each reduced by an absolute 0.5%, this would translate to approximately 2500 lives saved and savings of 10 million dollars to the Ontario health care system. Hence, in collaboration with the Canadian Critical Care Trials Group, the Crystalloid FLUID Choices for Hospitalized Patients (FLUID) trial will examine whether Ringer's Lactate as compared to Normal Saline reduces clinically important outcomes such as death, and hospital re-admissions - outcomes that are particularly relevant to hospitals and the health care system. This proposal is a large pragmatic cluster cross-over comparative effectiveness trial that will be conducted in both academic and community centres in Ontario. It will involve waivers of consent and a novel design making use of provincially available health administrative data through the Institute of Clinical Evaluative Sciences (ICES) to facilitate all data collected in the trial. The trial will answer this fundamental fluid resuscitation question with much less cost in comparison to an individual patient randomized controlled trial. It will help build expertise and capacity for future trials of similar design in the province of Ontario and throughout Canada. However, prior to embarking on a large-scale trial, it is imperative to conduct a pilot trial to determine feasibility and optimize the trial design.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30000 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Crystalloid FLUID Choices for Resuscitation of Hospital Patients: A Pragmatic Cluster Cross Over Pilot Trial|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||January 13, 2018|
|Actual Study Completion Date :||January 13, 2018|
Half of the hospitals will be allocated to start the 90-day test period using Normal Saline administered as 500 or 1000 ml boluses or infusions as specified by the treating physicians. After a 1 week run out, half of participating hospitals will have up to 2 weeks to switch out stock then will be crossed over to using Ringer's Lactate following a 1 week run in as 500 or 1000 ml boluses or infusions as specified by the treating physicians for the final 90-day test period.
Other: Ringer's Lactate
After a 1 week run in half of participating hospitals will be crossed over to using Ringer's Lactate as 500 or 1000 ml boluses or infusions as specified by the treating physicians for the second 90-day test period.
Half of the hospitals will be allocated to start the 90-day test period using Ringer's Lactate administered as 500 or 1000 ml boluses or infusions as specified by the treating physicians. After a 1 week run out, half of participating hospitals will have up to 2 weeks to switch out stock then will be crossed over to using Normal Saline following a 1 week run in as 500 or 1000 ml boluses or infusions as specified by the treating physicians in for the final 90-day test period.
Other: Normal Saline
After a 1 week run in half of participating hospitals will be crossed over to using Normal Saline as 500 or 1000 ml boluses or infusions as specified by the treating physicians for the final 90-day test period.
- Feasibility: adherence to protocol [ Time Frame: Up to six months ]Compliance defined as at least 80% of the prescribed study fluid being administered in the participating hospitals over the 2, 3-month study periods.
- Feasibility: time to research ethics board approval [ Time Frame: Up to three months ]Compliance defined as taking no longer than 3 months to achieve
- Feasibility: readiness to initiate protocol [ Time Frame: Up to three months ]Compliance defined as taking no longer than 3 months after ethics approval
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721485
|Hamilton General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|Ottawa Hospital Civic Campus|
|Ottawa, Ontario, Canada, 1053 Carling Ave|
|The Ottawa Hospital General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|Queensway Carleton Hosptial|
|Ottawa, Ontario, Canada, K2H 8P4|
|Principal Investigator:||Lauralyn McIntyre, MD MSc||Ottawa Hospital Research Institute|