CLASSIC (short-term outcomes)
Trial question
What is the role of intravenous fluid restriction in ICU patients with septic shock?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 1531
1531 patients (627 female, 904 male).
Inclusion criteria: patients with septic shock in the ICU who received at least 1 L of intravenous fluid.
Key exclusion criteria: septic shock for > 12 hours; life-threatening bleeding; acute burn injury involving > 10% of body surface area; pregnancy.
Interventions
N=755 restrictive fluid (no intravenous fluids administration unless extenuating circumstances occur).
N=776 standard fluid (no upper limit for the use of intravenous fluids).
Primary outcome
Death at day 90
42.3%
42.1%
42.3 %
31.7 %
21.1 %
10.6 %
0.0 %
Restrictive
fluid
Standard
fluid
No significant
difference ↔
No significant difference in death at day 90 (42.3% vs. 42.1%; AD 0.1%, 95% CI -4.7 to 4.9).
Secondary outcomes
No significant difference in serious adverse events (29.4% vs. 30.8%; ARD -1.7, 99% CI -7.7 to 4.3).
No significant difference in serious adverse reaction (4.1% vs. 4.1%; ARD -0.1, 99% CI -2.8 to 2.6).
No significant difference in days alive and out of the hospital (21 days vs. 33 days; ARD -12, 95% CI -30 to 6).
Conclusion
In patients with septic shock in the ICU who received at least 1 L of intravenous fluid, restrictive fluid was not superior to standard fluid with respect to death at day 90.
Reference
Tine S Meyhoff, Peter B Hjortrup, Jørn Wetterslev et al. Restriction of Intravenous Fluid in ICU Patients with Septic Shock. N Engl J Med. 2022 Jun 30;386(26):2459-2470.
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