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 Kiel; Morten 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

doi:10.1007/s00134-023-07114-8

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

10 Citations (Scopus)

Abstract

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 language	English
Journal	Intensive Care Medicine
Volume	49
Issue number	7
Pages (from-to)	820-830
Number of pages	11
ISSN	0342-4642
DOIs	https://doi.org/10.1007/s00134-023-07114-8
Publication status	Published - Jul 2023

Keywords

Adult
Critical Care
Humans
Intensive Care Units
Quality of Life
Shock, Septic/therapy
Survivors
Critical illness
Septic shock
Quality of life
Long-term outcomes
Sepsis
Cognitive function
Intravenous fluid

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10.1007/s00134-023-07114-8

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Kjær, M.-B. N., Meyhoff, T. S., Sivapalan, P., Granholm, A., Hjortrup, P. B., Madsen, M. B., Møller, M. H., Egerod, I., Wetterslev, J., Lange, T., Cronhjort, M., Laake, J. H., Jakob, S. M., Nalos, M., Ostermann, M., Gould, D., Cecconi, M., Malbrain, M. L. N. G., Ahlstedt, C., ... Perner, A. (2023). Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock. Intensive Care Medicine, 49(7), 820-830. https://doi.org/10.1007/s00134-023-07114-8

Kjær, M-BN , Meyhoff, TS , Sivapalan, P , Granholm, A , Hjortrup, PB , Madsen, MB , Møller, MH , Egerod, I , Wetterslev, J, Lange, T, Cronhjort, M, Laake, JH, Jakob, SM, Nalos, M, Ostermann, M, Gould, D, Cecconi, M, Malbrain, MLNG, Ahlstedt, C, Kiel, LB , Bestle, MH, Nebrich, L, Hildebrandt, T, Russell, L, Vang, M, Rasmussen, ML, Sølling, C, Brøchner, AC, Krag, M, Pfortmueller, C, Kriz, M, Siegemund, M, Albano, G, Aagaard, SR, Bundgaard, H, Crone, V, Wichmann, S, Johnstad, B, Martin, YK, Seidel, P, Mårtensson, J, Hollenberg, J, Wistrand, M, Donati, A, Barbara, E, Karvunidis, T, Hollinger, A, Carsetti, A, Lumlertgul, N, Joelsson-Alm, E, Lambiris, N, Aslam, TN, Friberg, FF, Vesterlund, GK, Mortensen, CB, Vestergaard, SR, Caspersen, SF, Jensen, DB, Borup, M, Rasmussen, BS & Perner, A 2023, 'Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock', Intensive Care Medicine, vol. 49, no. 7, pp. 820-830. https://doi.org/10.1007/s00134-023-07114-8

@article{eab88f9157bd4270bab39fcd5820c04f,

title = "Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock",

abstract = "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.",

keywords = "Adult, Critical Care, Humans, Intensive Care Units, Quality of Life, Shock, Septic/therapy, Survivors, Critical illness, Septic shock, Quality of life, Long-term outcomes, Sepsis, Cognitive function, Intravenous fluid",

author = "Kj{\ae}r, {Maj-Brit N{\o}rregaard} and Meyhoff, {Tine Sylvest} and Praleene Sivapalan and Anders Granholm and Hjortrup, {Peter Buhl} and Madsen, {Martin Bruun} and M{\o}ller, {Morten Hylander} and Ingrid Egerod and J{\o}rn Wetterslev and Theis Lange and Maria Cronhjort and Laake, {Jon Henrik} and Jakob, {Stephan M} and Marek Nalos and Marlies Ostermann and Doug Gould and Maurizio Cecconi and Malbrain, {Manu L N G} and Christian Ahlstedt and Kiel, {Louise Bendix} and Bestle, {Morten H} and Lars Nebrich and Thomas Hildebrandt and Lene Russell and Marianne Vang and Rasmussen, {Michael Lindhart} and Christoffer S{\o}lling and Br{\o}chner, {Anne Craveiro} and Mette Krag and Carmen Pfortmueller and Miroslav Kriz and Martin Siegemund and Giovanni Albano and Aagaard, {S{\o}ren Rosborg} and Helle Bundgaard and Vera Crone and Sine Wichmann and Bror Johnstad and Martin, {Yvonne Karin} and Philipp Seidel and Johan M{\aa}rtensson and Jacob Hollenberg and Mats Wistrand and Abele Donati and Enrico Barbara and Thomas Karvunidis and Alexa Hollinger and Andrea Carsetti and Nuttha Lumlertgul and Eva Joelsson-Alm and Nikolas Lambiris and Aslam, {Tayyba Naz} and Friberg, {Fredrik Femtehjell} and Vesterlund, {Gitte Kingo} and Mortensen, {Camilla Bekker} and Vestergaard, {Stine Rom} and Caspersen, {Sidsel Fjordbak} and Jensen, {Diana Bertelsen} and Morten Borup and Rasmussen, {Bodil Steen} and Anders Perner",

note = "{\textcopyright} 2023. The Author(s).",

year = "2023",

month = jul,

doi = "10.1007/s00134-023-07114-8",

language = "English",

volume = "49",

pages = "820--830",

journal = "Intensive Care Medicine",

issn = "0342-4642",

publisher = "Springer",

number = "7",

}

TY - JOUR

T1 - Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock

AU - Kjær, Maj-Brit Nørregaard

AU - Meyhoff, Tine Sylvest

AU - Sivapalan, Praleene

AU - Granholm, Anders

AU - Hjortrup, Peter Buhl

AU - Madsen, Martin Bruun

AU - Møller, Morten Hylander

AU - Egerod, Ingrid

AU - Wetterslev, Jørn

AU - Lange, Theis

AU - Cronhjort, Maria

AU - Laake, Jon Henrik

AU - Jakob, Stephan M

AU - Nalos, Marek

AU - Ostermann, Marlies

AU - Gould, Doug

AU - Cecconi, Maurizio

AU - Malbrain, Manu L N G

AU - Ahlstedt, Christian

AU - Kiel, Louise Bendix

AU - Bestle, Morten H

AU - Nebrich, Lars

AU - Hildebrandt, Thomas

AU - Russell, Lene

AU - Vang, Marianne

AU - Rasmussen, Michael Lindhart

AU - Sølling, Christoffer

AU - Brøchner, Anne Craveiro

AU - Krag, Mette

AU - Pfortmueller, Carmen

AU - Kriz, Miroslav

AU - Siegemund, Martin

AU - Albano, Giovanni

AU - Aagaard, Søren Rosborg

AU - Bundgaard, Helle

AU - Crone, Vera

AU - Wichmann, Sine

AU - Johnstad, Bror

AU - Martin, Yvonne Karin

AU - Seidel, Philipp

AU - Mårtensson, Johan

AU - Hollenberg, Jacob

AU - Wistrand, Mats

AU - Donati, Abele

AU - Barbara, Enrico

AU - Karvunidis, Thomas

AU - Hollinger, Alexa

AU - Carsetti, Andrea

AU - Lumlertgul, Nuttha

AU - Joelsson-Alm, Eva

AU - Lambiris, Nikolas

AU - Aslam, Tayyba Naz

AU - Friberg, Fredrik Femtehjell

AU - Vesterlund, Gitte Kingo

AU - Mortensen, Camilla Bekker

AU - Vestergaard, Stine Rom

AU - Caspersen, Sidsel Fjordbak

AU - Jensen, Diana Bertelsen

AU - Borup, Morten

AU - Rasmussen, Bodil Steen

AU - Perner, Anders

PY - 2023/7

Y1 - 2023/7

N2 - 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.

AB - 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.

KW - Adult

KW - Critical Care

KW - Humans

KW - Intensive Care Units

KW - Quality of Life

KW - Shock, Septic/therapy

KW - Survivors

KW - Critical illness

KW - Septic shock

KW - Quality of life

KW - Long-term outcomes

KW - Sepsis

KW - Cognitive function

KW - Intravenous fluid

UR - http://www.scopus.com/inward/record.url?scp=85161973059&partnerID=8YFLogxK

U2 - 10.1007/s00134-023-07114-8

DO - 10.1007/s00134-023-07114-8

M3 - Journal article

C2 - 37330928

SN - 0342-4642

VL - 49

SP - 820

EP - 830

JO - Intensive Care Medicine

JF - Intensive Care Medicine

IS - 7

ER -

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

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