Long-term effects of restriction of intravenous fluid in adult intensive care unit (ICU) patients with septic shock
Primary result · MortalityResult — go to the resultAbsolute risk difference 1.5 %-points 99% CI - 4.8 to 7.8Authors' conclusion
Among adult ICU patients with septic shock, restrictive versus standard IV fluid therapy resulted in similar survival, HRQoL, and cognitive function at 1 year, but clinically important differences could not be ruled out.
Study context
- Population
- Adult ICU patients with septic shock in the CLASSIC trialrandomised
- Participants
- 1,554 patients
- Comparison
- Restrictive vs standard intravenous (IV) fluid therapy
- Restrictive-fluidn = 746
- Standard-fluidn = 767reference
- Primary endpoint
- Mortality, HRQoL (EQ-5D-5L index values, EuroQol (EQ) visual analogue scale (VAS)) and cognitive function (Mini MoCA)
- Follow-up
- 1 year
Methodological detailspre-planned analyses, multiple imputation for missing data
- Pre-planned analyses
- Multiple imputation for missing data
Primary result
Mortality
Absolute risk difference
1.5 %-points
99% CI - 4.8 to 7.8
Events by treatment group
As reported in the abstract
Further findings
| Outcome | Estimate |
|---|---|
| HRQoL, EQ-5D-5L index values · 1 year | mean difference 0.00 (99% CI - 0.06 to 0.05) |
| HRQoL, EQ VAS · 1 year | mean difference - 0.65 (CI - 5.40 to 4.08) |
| Cognitive function, Mini MoCA · 1 year | mean difference - 0.14 (CI - 1.59 to 1.14) |
- Health-related quality of life (HRQoL), EQ-5D-5L index values: deceased assigned 0; multiple imputation; data in 91.3%
- Cognitive function, Mini MoCA: deceased assigned 0; multiple imputation; data in 86.3%
Survivors only · 1 year
- Results for survivors only similar in both groups
Original publication
Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock. Intensive Care Med. Published 18 June 2023. doi:10.
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