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Restriction of Intravenous Fluid in ICU Patients with Septic Shock
Tine S Meyhoff1, Peter B Hjortrup1, Jørn Wetterslev1
1From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).
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.).
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