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

Maj Brit Nørregaard Kjær*, Tine Sylvest Meyhoff, Praleene Sivapalan, Anders Granholm, Peter Buhl Hjortrup, Martin Bruun Madsen, Morten Hylander Møller, Ingrid Egerod, Jørn Wetterslev, Theis Lange, Maria Cronhjort, Jon Henrik Laake, Stephan M. Jakob, Marek Nalos, Marlies Ostermann, Doug Gould, Maurizio Cecconi, Manu L.N.G. Malbrain*, Christian Ahlstedt, Louise Bendix KielMorten H. Bestle, Lars Nebrich, Thomas Hildebrandt, Lene Russell, Marianne Vang, Michael Lindhart Rasmussen, Christoffer Sølling, Anne Craveiro Brøchner, Mette Krag, Carmen Pfortmueller, Miroslav Kriz, Martin Siegemund, Giovanni Albano, Søren Rosborg Aagaard, Helle Bundgaard, Vera Crone, Sine Wichmann, Bror Johnstad, Yvonne Karin Martin, Philipp Seidel, Johan Mårtensson, Jacob Hollenberg, Mats Wistrand, Abele Donati, Enrico Barbara, Thomas Karvunidis, Alexa Hollinger, Andrea Carsetti, Nuttha Lumlertgul, Eva Joelsson-Alm, Nikolas Lambiris, Tayyba Naz Aslam, Fredrik Femtehjell Friberg, Gitte Kingo Vesterlund, Camilla Bekker Mortensen, Stine Rom Vestergaard, Sidsel Fjordbak Caspersen, Diana Bertelsen Jensen, Morten Borup, Bodil Steen Rasmussen, Anders Perner

*Corresponding author for this work

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Purpose: To assess long-term outcomes of restrictive versus standard intravenous (IV) fluid therapy in adult intensive care unit (ICU) patients with septic shock included in the European Conservative versus Liberal Approach to Fluid Therapy in Septic Shock in Intensive Care (CLASSIC) trial. Methods: We conducted the pre-planned analyses of mortality, health-related quality of life (HRQoL) using EuroQol (EQ)-5D-5L index values and EQ visual analogue scale (VAS), and cognitive function using Mini Montreal Cognitive Assessment (Mini MoCA) test at 1 year. Deceased patients were assigned numerical zero for HRQoL as a state equal to death and zero for cognitive function outcomes as worst possible score, and we used multiple imputation for missing data on HRQoL and cognitive function. Results: Among 1554 randomized patients, we obtained 1-year data on mortality in 97.9% of patients, HRQoL in 91.3%, and cognitive function in 86.3%. One-year mortality was 385/746 (51.3%) in the restrictive-fluid group versus 383/767 (49.9%) in the standard-fluid group, absolute risk difference 1.5%-points [99% confidence interval (CI) − 4.8 to 7.8]. Mean differences were 0.00 (99% CI − 0.06 to 0.05) for EQ-5D-5L index values, − 0.65 for EQ VAS (− 5.40 to 4.08), and − 0.14 for Mini MoCA (− 1.59 to 1.14) for the restrictive-fluid group versus the standard-fluid group. The results for survivors only were similar in both groups. Conclusions: Among adult ICU patients with septic shock, restrictive versus standard IV fluid therapy resulted in similar survival, HRQoL, and cognitive function at 1 year, but clinically important differences could not be ruled out.

Original languageEnglish
JournalIntensive Care Medicine
Issue number7
Pages (from-to)820-830
Publication statusPublished - Jul 2023

Bibliographical note

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© 2023, The Author(s).


  • Cognitive function
  • Critical illness
  • Intravenous fluid
  • Long-term outcomes
  • Quality of life
  • Sepsis
  • Septic shock


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