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Restriction of Intravenous Fluid in ICU Patients with Septic Shock.

Authors :
Meyhoff TS
Hjortrup PB
Wetterslev J
Sivapalan P
Laake JH
Cronhjort M
Jakob SM
Cecconi M
Nalos M
Ostermann M
Malbrain M
Pettilä V
Møller MH
Kjær MN
Lange T
Overgaard-Steensen C
Brand BA
Winther-Olesen M
White JO
Quist L
Westergaard B
Jonsson AB
Hjortsø CJS
Meier N
Jensen TS
Engstrøm J
Nebrich L
Andersen-Ranberg NC
Jensen JV
Joseph NA
Poulsen LM
Herløv LS
Sølling CG
Pedersen SK
Knudsen KK
Straarup TS
Vang ML
Bundgaard H
Rasmussen BS
Aagaard SR
Hildebrandt T
Russell L
Bestle MH
Schønemann-Lund M
Brøchner AC
Elvander CF
Hoffmann SKL
Rasmussen ML
Martin YK
Friberg FF
Seter H
Aslam TN
Ådnøy S
Seidel P
Strand K
Johnstad B
Joelsson-Alm E
Christensen J
Ahlstedt C
Pfortmueller CA
Siegemund M
Greco M
Raděj J
Kříž M
Gould DW
Rowan KM
Mouncey PR
Perner A
Source :
The New England journal of medicine [N Engl J Med] 2022 Jun 30; Vol. 386 (26), pp. 2459-2470. Date of Electronic Publication: 2022 Jun 17.
Publication Year :
2022

Abstract

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).<br />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.<br />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.<br />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.).<br /> (Copyright © 2022 Massachusetts Medical Society.)

Details

Language :
English
ISSN :
1533-4406
Volume :
386
Issue :
26
Database :
MEDLINE
Journal :
The New England journal of medicine
Publication Type :
Academic Journal
Accession number :
35709019
Full Text :
https://doi.org/10.1056/NEJMoa2202707