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Normosol-R vs Lactated Ringers in the Critically Ill: A Randomized Trial
Edward T Qian1, Ryan M Brown2, Karen E Jackson3
1Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Nashville, TN; Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN.
Background:
Balanced crystalloid solutions may improve clinical outcomes compared with saline for some critically ill adults, but it is unclear whether differences in composition between balanced crystalloid solutions affect outcomes.
Research Question:
Does the choice of balanced crystalloid solutions (Normosol-R vs lactated Ringers) impact acid-base status, organ function, or outcomes for critically ill adults?
Study Design And Methods:
This pragmatic, cluster-randomized, multiple-crossover trial at an academic medical center in the United States compared the use of Normosol-R vs lactated Ringers among critically ill adults. The primary outcome was the plasma bicarbonate (HCO3-) concentration between enrollment and 7 days. Secondary outcomes included receipt of kidney replacement therapy and death by day 30.
Results:
Between June 1, 2018, and January 31, 2019, 2,084 patients were enrolled. The median age was 59 years, 1,006 patients (48.3%) were female, and the median Sequential Organ Failure Assessment score was 5 (interquartile range, 3-8). HCO3- concentration between enrollment and 7 days did not differ between the Normosol-R and lactated Ringers groups (mean difference, -0.12 mmol/dL; 95% CI, -0.61 to 0.36; P = .61). A total of 58 patients (6.0%) in the Normosol-R group and 47 patients (5.0%) in the lactated Ringers group received new kidney replacement therapy (absolute risk difference, 1.0%; 95% CI, -1.2% to 3.1%). Death by day 30 occurred in 172 patients (16.3%) in the Normosol-R group and 164 patients (16.0%) in the lactated Ringers group (absolute risk difference, 0.3%; 95% CI, -2.9% to 3.6%).
Interpretation:
Among critically ill adults, the use of Normosol-R for IV fluid therapy did not affect plasma HCO3- concentrations or clinical outcomes compared with lactated Ringers.
Clinical Trial Registration:
ClinicalTrials.gov; No.: NCT03537898; URL: www.
Clinicaltrials:
gov.
