SMART-MED and SMART-SURG
Trial question
What is the effect of balanced crystalloids for intravenous fluid administration in critically ill adult patients?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 15802
15802 patients (6705 female, 9097 male).
Inclusion criteria: critically ill adult patients requiring intravenous fluid administration.
Key exclusion criteria: age < 18 years old.
Interventions
N=7942 balanced crystalloids (either lactated Ringer's solution or Plasma-Lyte A).
N=7860 normal saline (0.9% sodium chloride).
Primary outcome
Rate of major adverse kidney event within 30 days
14.3%
15.4%
15.4 %
11.6 %
7.7 %
3.9 %
0.0 %
Balanced
crystalloids
Normal
saline
Significant
decrease ▼
NNT = 90
Significant decrease in the rate of major adverse kidney event within 30 days (14.3% vs. 15.4%; aOR 0.9, 95% CI 0.82 to 0.99).
Secondary outcomes
Borderline significant increase in in-hospital death at 30 days (10.3% vs. 11.1%).
No significant difference in new RRT (2.5% vs. 2.9%; aOR 0.84, 95% CI 0.68 to 1.02).
No significant difference in persistent renal dysfunction (6.4% vs. 6.6%; aOR 0.96, 96% CI 0.84 to 1.1).
Safety outcomes
No significant differences in change in creatinine levels, death in the hospital before 60 days.
Conclusion
In critically ill adult patients requiring intravenous fluid administration, balanced crystalloids were superior to normal saline with respect to the rate of major adverse kidney event within 30 days.
Reference
Semler MW, Self WH, Wanderer JP et al. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):829-839.
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