BACKGROUND: Intravenous fluids are recommended for the treatment of patients who are in septic shock, but higher fluid volumes have been associated with harm in patients who are in the intensive care unit (ICU). METHODS: In this international, randomized trial, we assigned patients with septic shock in the ICU who had received at least 1 liter of intravenous fluid to receive restricted intravenous fluid or standard intravenous fluid therapy; patients were included if the onset of shock had been within 12 hours before screening. The primary outcome was death from any cause within 90 days after randomization. RESULTS: We enrolled 1554 patients; 770 were assigned to the restrictive-fluid group and 784 to the standard-fluid group. Primary outcome data were available for 1545 patients (99.4%). In the ICU, the restrictive-fluid group received a median of 1798 ml of intravenous fluid (interquartile range, 500 to 4366); the standard-fluid group received a median of 3811 ml (interquartile range, 1861 to 6762). At 90 days, death had occurred in 323 of 764 patients (42.3%) in the restrictive-fluid group, as compared with 329 of 781 patients (42.1%) in the standard-fluid group (adjusted absolute difference, 0.1 percentage points; 95% confidence interval [CI], -4.7 to 4.9; P = 0.96). In the ICU, serious adverse events occurred at least once in 221 of 751 patients (29.4%) in the restrictive-fluid group and in 238 of 772 patients (30.8%) in the standard-fluid group (adjusted absolute difference, -1.7 percentage points; 99% CI, -7.7 to 4.3). At 90 days after randomization, the numbers of days alive without life support and days alive and out of the hospital were similar in the two groups. CONCLUSIONS: Among adult patients with septic shock in the ICU, intravenous fluid restriction did not result in fewer deaths at 90 days than standard intravenous fluid therapy. (Funded by the Novo Nordisk Foundation and others; CLASSIC ClinicalTrials.gov number, NCT03668236.).

From Copenhagen University Hospital Rigshospitalet

N Engl J Med. 2022 Jun 30;386(26):2518-2519. doi: 10.1056/NEJMe2206160. PubMed

Nat Rev Nephrol. 2022 Oct;18(10):607-608. doi: 10.1038/s41581-022-00609-5. PubMed

N Engl J Med. 2022 Sep 1;387(9):856. doi: 10.1056/NEJMc2210366. PubMed

N Engl J Med. 2022 Sep 1;387(9):857. doi: 10.1056/NEJMc2210366. PubMed

Anaesthesiologie. 2023 Feb;72(2):128-129. doi: 10.1007/s00101-022-01223-7. PubMed

Anaesthesiologie. 2023 Nov;72(11):821-830. doi: 10.1007/s00101-023-01334-9. PubMed

References provided by Crossref.org

Atrial fibrillation in critical illness: state of the art

Effects of restrictive fluid therapy on the time to resolution of hyperlactatemia in ICU patients with septic shock. A secondary post hoc analysis of the CLASSIC randomized trial

Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock

See more in PubMed

ClinicalTrials.gov
NCT03668236