CLASSIC (long-term outcomes)
Trial question
What is the role of restrictive intravenous fluid therapy in adult ICU patients with septic shock?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 1549
1549 patients (636 female, 913 male).
Inclusion criteria: adult ICU patients with septic shock.
Key exclusion criteria: septic shock for > 12 hours at the time of screening, life-threatening bleeding, acute burn injury of > 10% of the body surface area, pregnancy.
Interventions
N=767 restrictive-fluid therapy (no intravenous fluid given unless extenuating circumstances occur).
N=782 standard-fluid therapy (no upper limit for the use of intravenous fluids).
Primary outcome
Death at 1 year
51.3%
49.9%
51.3 %
38.5 %
25.6 %
12.8 %
0.0 %
Restrictive-fluid
therapy
Standard-fluid
therapy
No significant
difference ↔
No significant difference in death at 1 year (51.3% vs. 49.9%; RR 1.03, 99% CI 0.91 to 1.17).
Secondary outcomes
No significant difference in European QoL 5 Domains 5 Levels index values at 1 year (0 vs. 0; RR 0.99, 99% CI 0.85 to 1.16).
No significant difference in European QoL VAS score at 1 year (0 points vs. 0 points; RR 0.98, 99% CI 0.84 to 1.14).
No significant difference in Mini Montreal Cognitive Assessment test at 1 year (0 vs. 0; RR 0.99, 99% CI 0.86 to 1.14).
Conclusion
In adult ICU patients with septic shock, restrictive-fluid therapy was not superior to standard-fluid therapy with respect to death at 1 year.
Reference
Maj-Brit Nørregaard Kjær, Tine Sylvest Meyhoff, Praleene Sivapalan et al. Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock. Intensive Care Med. 2023 Jul;49(7):820-830.
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