Effets de différents solutés de remplissage sur l'osmolalité plasmatique

Butscher, Karin; Jamali, Seyedeh Narges; Talib, Rosnita A.; Ravussin, P.; Poggi-Bach, J; Ecoffey, Claude

doi:10.1016/s0750-7658(96)89475-5

Cited by 7 publications

(2 citation statements)

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“…The lactate in RL may accumulate in the setting of liver failure and may influence clinical diagnoses and clinical decision-making [11][12][13]. Moreover, RL has a lower osmolarity in comparison to NS; when administered rapidly in large volumes, RL theoretically reduces plasma osmolarity and increases the risk of edema formation [14], which raises potential concern for patients with cerebral edema.…”

Section: Introductionmentioning

confidence: 99%

A Hospital-Wide Open-Label Cluster Crossover Pragmatic Comparative Effectiveness Randomized Trial Comparing Normal Saline to Ringer’s Lactate: Protocol and Statistical Analysis Plan of The FLUID Trial

Shaw,

Ouyang,

Fergusson

et al. 2023

JMIR Res Protoc

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Background Normal saline (NS) and Ringer’s lactate (RL) are the most common crystalloids given to hospitalized patients. Despite concern about possible harm associated with NS (eg, hyperchloremic metabolic acidosis, impaired kidney function, and death), few large multicenter randomized trials focused on critically ill patients have compared these fluids. Uncertainty exists about the effects of these fluids on clinically important outcomes across all hospitalized patients. Objective The FLUID trial is a pragmatic, multicenter, 2×2 cluster crossover comparative effectiveness randomized trial that aims to evaluate the effectiveness of a hospital-wide policy that stocks either NS or RL as the main crystalloid fluid in 16 hospitals across Ontario, Canada. Methods All hospitalized 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 hospitalization. Secondary outcomes include death, hospital readmission, dialysis, reoperation, postoperative reintubation, 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 data set 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. Trial Registration ClinicalTrials.gov NCT04512950; https://classic.clinicaltrials.gov/ct2/show/NCT04512950 International Registered Report Identifier (IRRID) DERR1-10.2196/51783

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Section: Introductionmentioning

confidence: 99%

A Hospital-Wide Open-Label Cluster Crossover Pragmatic Comparative Effectiveness Randomized Trial Comparing Normal Saline to Ringer’s Lactate: Protocol and Statistical Analysis Plan of The FLUID Trial

Shaw,

Ouyang,

Fergusson

et al. 2023

JMIR Res Protoc

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“… 12–14 Although the lactate in Ringer’s lactate does not cause a metabolic acidosis, it may accumulate in the setting of liver failure and may influence clinical diagnoses and clinical decision making. 15–17 Moreover, Ringer’s has a lower osmolarity in comparison with 0.9% saline and when administered rapidly in large volumes could theoretically reduce plasma osmolarity and increase the risk of oedema formation, 18 which may be concerning for patients with cerebral oedema.…”

Section: Introductionmentioning

confidence: 99%

FLUID trial: a protocol for a hospital-wide open-label cluster crossover pragmatic comparative effectiveness randomised pilot trial

et al. 2018

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Introduction0.9% saline and Ringer’s lactate are the two most common resuscitation crystalloid fluids. 0.9% saline may lead to hyperchloraemic metabolic acidosis and may be associated with impaired kidney function and death. Few large multicentre randomised trials have been conducted to evaluate the effect of these two fluids on clinically important outcomes.MethodsFLUID is a pragmatic pilot cluster randomised crossover trial in which four hospitals will be randomised to normal saline or Ringer’s lactate for 14 weeks, then crossover to the alternative fluid for the subsequent 14 weeks after 1 to 3 week transition. With waiver of informed consent, all adult and paediatric patients admitted to participating sites will be included in the FLUID trial except for neonates. Primary feasibility outcome is study fluid protocol adherence (target:≥80%). Secondary feasibility outcomes include time to research ethics board (REB) approval and readiness to trial initiation (≤3 months from REB submission and approval). Primary (composite of death or re-admission to hospital in first 90 days of index hospitalisation) and secondary clinical outcomes for the future large FLUID trial will be described. Protocol adherence will be collected by site at specified time points. All clinical data will be obtained at patient level through provincial health administrative data held at the Institute for Clinical Evaluative Sciences (ICES). Event rates for the primary and secondary outcomes will be described using frequencies and proportions with 95% CIs. Intracluster and interperiod correlation coefficients will be calculated from population-level data available at ICES.Ethics and disseminationThe study protocol has been approved by the Ottawa Health Science Research Ethics Board. The FLUID pilot will determine feasibility, and ICES data across all potential sites in Ontario will allow calculation of sample size parameter estimates to inform the design and implementation of the large trial.Trial registration numberNCT02721485; Pre-results.

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