Restriction of Intravenous Fluid in ICU Patients with Septic Shock.
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Meyhoff Tine S, Hjortrup Peter B, Wetterslev Jørn, Sivapalan Praleene, Laake Jon H, Cronhjort Maria, Jakob Stephan M, Cecconi Maurizio, Nalos Marek, Ostermann Marlies, Malbrain Manu, Pettilä Ville, Møller Morten H, Kjær Maj-Brit N, Lange Theis, Overgaard-Steensen Christian, Brand Björn A, Winther-Olesen Marie, White Jonathan O, Quist Lars, Westergaard Bo, Jonsson Andreas B, Hjortsø Carl J S, Meier Nick, Jensen Thomas S, Engstrøm Janus, Nebrich Lars, Andersen-Ranberg Nina C, Jensen Jacob V, Joseph Neeliya A, Poulsen Lone M, Herløv Louise S, Sølling Christoffer G, Pedersen Susan K, Knudsen Kurt K, Straarup Therese S, Vang Marianne L, Bundgaard Helle, Rasmussen Bodil S, Aagaard Søren R, Hildebrandt Thomas, Russell Lene, Bestle Morten H, Schønemann-Lund Martin, Brøchner Anne C, Elvander Claes F, Hoffmann Søren K L, Rasmussen Michael L, Martin Yvonne K, Friberg Fredrik F, Seter Herman, Aslam Tayyba N, Ådnøy Sigrid, Seidel Philipp, Strand Kristian, Johnstad Bror, Joelsson-Alm Eva, Christensen Jens, Ahlstedt Christian, Pfortmueller Carmen A, Siegemund Martin, Greco Massimiliano, Raděj Jaroslav, Kříž Miroslav, Gould Doug W, Rowan Kathy M, Mouncey Paul R, Perner Anders, CLASSIC Trial Group
Аннотация
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.).