Restriction of Intravenous Fluid in ICU Patients with Septic Shock
Open accessAbstract
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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Two trials investigating intravenous fluid restriction in patients with acute lung injury or septic shock produced conflicting results.
“However, two trials investigating intravenous fluid restriction in patients with acute lung injury or septic shock produced conflicting results.29,30”
From Low versus standard calorie and protein feeding in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3). (2023) · cites this paper as [29]
The Discussion identifies this as a randomized trial of intravenous fluid restriction in ICU patients with septic shock and reports no significant difference in 90-day mortality versus standard therapy. This supports the septic-shock trial and its result, but our copy does not establish that its findings conflict with those of the acute-lung-injury trial. (LLM, conf=0.84)
Experimental — accuracy not yet measuredFixed-volume mandates embedded in SEP-1 may conflict with individualized, physiology-driven care, particularly for patients at elevated risk of fluid-related harm.
“fixed-volume mandates embedded in SEP-1 may conflict with individualized, physiology-driven care, particularly for patients at elevated risk of fluid-related harm [22,23].”
From Artificial Intelligence to Facilitate SEP-1 Measure Compliance and Fluid Management in Sepsis (2026) · cites this paper as [22]
The paper’s opening passage says Surviving Sepsis Campaign guidelines suggest an initial fixed volume of 30 ml/kg despite low-certainty evidence, and it reports associations between higher fluid volumes and harm. It does not discuss SEP-1, characterize its requirements as mandates, or assess whether they conflict with individualized care. The Discussion reports no significant difference in mortality or serious adverse events between the trial’s restrictive- and standard-fluid groups. (LLM, conf=0.83)
Experimental — accuracy not yet measuredPrevious studies examining restricted versus liberal fluid strategies had patients enrolled after approximately 30 mL/kg of crystalloid fluid administration.
“While previous studies examining restricted versus liberal fluid strategies had patients enrolled after an approximately 30 mL/kg of crystalloid fluid administration, fixed-volume mandates embedded in SEP-1 may conflict with individualized, physiology-driven care, particularly for patients at elevated risk of fluid-related harm [22,23].”
From Artificial Intelligence to Facilitate SEP-1 Measure Compliance and Fluid Management in Sepsis (2026) · cites this paper as [22]
The Interventions section says patients had received at least 1 liter of intravenous fluid before screening, and Table 1 reports median pre-randomization volumes of 3000–3200 ml. But the Statistical Analysis table note defines those volumes as including crystalloids, colloids, and blood products; the paper does not establish that patients were enrolled after approximately 30 ml/kg of crystalloid specifically. (LLM, conf=0.86)
Experimental — accuracy not yet measuredContemporary trials support equipoise between liberal and restrictive early fluid strategies.
“For hemodynamic management, contemporary trials support equipoise between liberal and restrictive early fluid strategies, reinforcing the rationale for adaptive, physiology-guided resuscitation [22,23].”
From Artificial Intelligence to Facilitate SEP-1 Measure Compliance and Fluid Management in Sepsis (2026) · cites this paper as [22]
The Discussion reports no significant difference in 90-day mortality between restrictive and standard fluid therapy, supporting uncertainty about which approach is better. But the Trial Patients section says participants had already received at least 1 liter of fluid, and the trial compared subsequent ICU treatment with standard therapy—not liberal versus restrictive initial resuscitation. The cited trial therefore supports a narrower claim than the one about early fluid strategies. (LLM, conf=0.86)
Experimental — accuracy not yet measuredRecent randomized trials in emergency department and intensive care unit populations have not shown a mortality benefit for restrictive versus liberal fluid strategies after initial resuscitation.
“In contemporary high-resource settings, recent randomized trials in emergency department and intensive care unit populations have not shown a mortality benefit for restrictive versus liberal fluid strategies after initial resuscitation [22,23].”
From Artificial Intelligence to Facilitate SEP-1 Measure Compliance and Fluid Management in Sepsis (2026) · cites this paper as [22]
In patients with septic shock in the ICU, Meyhoff et al. found that a restrictive strategy did not reduce mortality compared with usual care but did reduce cumulative fluid exposure.
“In patients with septic shock in the ICU, Meyhoff et al. found that a restrictive strategy did not reduce mortality compared with usual care but did reduce cumulative fluid exposure [22].”
From Artificial Intelligence to Facilitate SEP-1 Measure Compliance and Fluid Management in Sepsis (2026) · cites this paper as [22]
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Influential
- Authors
- Meyhoff, T. S., Hjortrup, P. B., Wetterslev, J., Sivapalan, P., Laake, J. H., Cronhjort, M., Jakob, S. M., Cecconi, M., Nalos, M., Ostermann, M., Malbrain, M., Pettilä, V., Møller, M. H., Kjær, M.-B. N., Lange, T., Overgaard-Steensen, C., Brand, B. A., Winther-Olesen, M., White, J. O., Quist, L., Westergaard, B., Jonsson, A. B., Hjortsø, C. J. S., Meier, N., Jensen, T. S., Engstrøm, J., Nebrich, L., Andersen-Ranberg, N. C., Jensen, J. V., Joseph, N. A., Poulsen, L. M., Herløv, L. S., Sølling, C. G., Pedersen, S. K., Knudsen, K. K., Straarup, T. S., Vang, M. L., Bundgaard, H., Rasmussen, B. S., Aagaard, S. R., Hildebrandt, T., Russell, L., Bestle, M. H., Schønemann-Lund, M., Brøchner, A. C., Elvander, C. F., Hoffmann, S. K. L., Rasmussen, M. L., Martin, Y. K., Friberg, F. F., Seter, H., Aslam, T. N., Ådnøy, S., Seidel, P., Strand, K., Johnstad, B., Joelsson-Alm, E., Christensen, J., Ahlstedt, C., Pfortmueller, C. A., Siegemund, M., Greco, M., Raděj, J., Kříž, M., Gould, D. W., Rowan, K. M., Mouncey, P. R., & Perner, A.
- Affiliations
- University of Copenhagen (DK)
- From 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 ...
- ORCID
- 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
- Westergaard, Bo
- Jonsson, Andreas B.
- Hjortsø, Carl J.S.
- Meier, Nick
- Joseph, Neeliya A.
- Poulsen, Lone M.
- Herløv, Louise S.
- Sølling, Christoffer G.
- Rasmussen, Bodil S.
- Hildebrandt, Thomas
- Russell, Lene
- Bestle, Morten H.
- Brøchner, Anne C.
- Martin, Yvonne K.
- Friberg, Fredrik F.
- Aslam, Tayyba N.
- Seidel, Philipp
- Strand, Kristian
- Ahlstedt, Christian
- Pfortmueller, Carmen A.
- Siegemund, Martin
- Greco, Massimiliano
- Kříž, Miroslav
- Gould, Doug W.
- Rowan, Kathy M.
- Mouncey, Paul R.
- Perner, Anders
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2022-06-30
- Volume
- 386
- Issue
- 26
- Pages
- 2459-2470
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4283011822
- Cited by
- 427
- References
- 32
- Citations by year
- 2026: 100 · 2025: 86 · 2024: 96 · 2023: 114 · 2022: 31
- FWCI
- 59.35
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, other-oa)
- University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion, other-oa)
- Bern Open Repository and Information System (University of Bern) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- VBN Forskningsportal (Aalborg Universitet) (submittedVersion, other-oa)
- Funders
- Novo Nordisk Fonden (NNF17OC0028608)
- Topics
- Health Sciences › Medicine › Epidemiology › Sepsis Diagnosis and Treatment
- Health Sciences › Medicine › Surgery › Hemodynamic Monitoring and Therapy
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Keywords
- septic shock, fluid restriction, intravenous fluid therapy, intensive care unit, 90-day mortality, serious adverse events, fluid overload, critically ill adults
- MeSH terms
- Adult, Critical Care, Fluid Therapy, Humans, Intensive Care Units, Shock, Septic, Administration, Intravenous
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