BASE
Trial question
What is the role of Normosol-R for intravenous fluid therapy in critically ill patients?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
48.0% female
52.0% male
N = 2084
2084 patients (1006 female, 1078 male).
Inclusion criteria: adult patients admitted to the medical ICU.
Key exclusion criteria: age < 18 years; incarceration.
Interventions
N=1056 Normosol-R (receipt of Normosol®-R pH 7.4 whenever an isotonic IV crystalloid fluid administration is ordered).
N=1028 lactated Ringer's (receipt of lactated Ringer's whenever an isotonic IV crystalloid fluid administration is ordered).
Primary outcome
Plasma bicarbonate concentration at day 7
2.58
2.47
2.6 mmol/dL
1.9 mmol/dL
1.3 mmol/dL
0.6 mmol/dL
0.0 mmol/dL
Normosol-R
Lactated
Ringer's
No significant
difference ↔
No significant difference in plasma bicarbonate concentration at day 7 (2.58 mmol/dL vs. 2.47 mmol/dL; MD -0.12, 95% CI -0.61 to 0.36).
Secondary outcomes
No significant difference in bicarbonate concentration < 20 mmol/L (50.8% vs. 48.4%; AD 2.4%, 95% CI -2 to 6.9).
No significant difference in hospital death at day 30 (16.3% vs. 16%; AD 0.3%, 95% CI -2.9 to 3.6).
No significant difference in the rate of major adverse kidney event within 30 days (27.4% vs. 25.3%; AD 2.1%, 95% CI -1.8 to 6).
Conclusion
In adult patients admitted to the medical ICU, Normosol-R was equivalent to lactated Ringer's with respect to plasma bicarbonate concentration at day 7.
Reference
Edward T Qian, Ryan M Brown, Karen E Jackson et al. Normosol-R versus Lactated Ringers in the Critically Ill: A Randomized Trial. Chest. 2025 Feb 17:S0012-3692(25)00165-5. Online ahead of print.
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