Long-term patient-important outcomes after septic shock: a protocol for 1-year follow-up of the CLASSIC-trial

Maj-Brit Nørregaard Kjaer; Tine Sylvest Meyhoff; Martin Bruun Madsen; Peter Buhl Hjortrup; Morten Hylander Møller; Ingrid Egerod; Jørn Wetterslev; Theis Lange; Maria Cronhjort; Jon Henrik Laake; Stephan M Jakob; Marek Nalos; Ville Pettilä; Iwan C C van der Horst; Marlies Ostermann; Paul Mouncey; Maurizio Cecconi; Ricard Ferrer; Manu L N G Malbrain; Christian Ahlstedt; Søren Hoffmann; Morten H Bestle; Louise Gyldensted; Lars Nebrich; Lene Russell; Marianne Vang; Christoffer Sølling; Anne Craveiro Brøchner; Bodil Steen Rasmussen; Anders Perner

doi:10.1111/aas.13519

Long-term patient-important outcomes after septic shock: a protocol for 1-year follow-up of the CLASSIC-trial

Maj-Brit Nørregaard Kjaer, Tine Sylvest Meyhoff, Martin Bruun Madsen, Peter Buhl Hjortrup, Morten Hylander Møller, Ingrid Egerod, Jørn Wetterslev, Theis Lange, Maria Cronhjort, Jon Henrik Laake, Stephan M Jakob, Marek Nalos, Ville Pettilä, Iwan C C van der Horst, Marlies Ostermann, Paul Mouncey, Maurizio Cecconi, Ricard Ferrer, Manu L N G Malbrain, Christian AhlstedtSøren Hoffmann, Morten H Bestle, Louise Gyldensted, Lars Nebrich, Lene Russell, Marianne Vang, Christoffer Sølling, Anne Craveiro Brøchner, Bodil Steen Rasmussen, Anders Perner

4 Citations (Scopus)

Abstract

BACKGROUND: In patients with septic shock, mortality is high, and survivors experience long-term physical, mental and social impairments. The ongoing Conservative vs Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial assesses the benefits and harms of a restrictive vs standard-care intravenous (IV) fluid therapy. The hypothesis is that IV fluid restriction improves patient-important long-term outcomes.

AIM: To assess the predefined patient-important long-term outcomes in patients randomised into the CLASSIC trial.

METHODS: In this pre-planned follow-up study of the CLASSIC trial, we will assess all-cause mortality, health-related quality of life (HRQoL) and cognitive function 1 year after randomisation in the two intervention groups. The 1-year mortality will be collected from electronic patient records or central national registries in most participating countries. We will contact survivors and assess EuroQol 5-Dimension, -5-Level (EQ-5D-5L) and EuroQol-Visual Analogue Scale and Montreal Cognitive Assessment 5-minute protocol score. We will analyse mortality by logistic regression and use general linear models to assess HRQoL and cognitive function.

DISCUSSION: With this pre-planned follow-up study of the CLASSIC trial, we will provide patient-important data on long-term survival, HRQoL and cognitive function of restrictive vs standard-care IV fluid therapy in patients with septic shock.

Original language	English
Journal	Acta Anaesthesiologica Scandinavica
Volume	64
Issue number	3
Pages (from-to)	410–416
Number of pages	7
ISSN	0001-5172
DOIs	https://doi.org/10.1111/aas.13519
Publication status	Published - Mar 2020

Keywords

cognitive function
follow-up
HRQoL
IV fluid therapy
patient important outcomes
randomised clincial trial

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10.1111/aas.13519

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Kjaer, M.-B. N., Meyhoff, T. S., Madsen, M. B., Hjortrup, P. B., Møller, M. H., Egerod, I., Wetterslev, J., Lange, T., Cronhjort, M., Laake, J. H., Jakob, S. M., Nalos, M., Pettilä, V., van der Horst, I. C. C., Ostermann, M., Mouncey, P., Cecconi, M., Ferrer, R., L N G Malbrain, M., ... Perner, A. (2020). Long-term patient-important outcomes after septic shock: a protocol for 1-year follow-up of the CLASSIC-trial. Acta Anaesthesiologica Scandinavica, 64(3), 410–416. https://doi.org/10.1111/aas.13519

Kjaer, M-BN , Meyhoff, TS , Madsen, MB , Hjortrup, PB , Møller, MH , Egerod, I , Wetterslev, J, Lange, T, Cronhjort, M, Laake, JH, Jakob, SM, Nalos, M, Pettilä, V, van der Horst, ICC, Ostermann, M, Mouncey, P, Cecconi, M, Ferrer, R, L N G Malbrain, M, Ahlstedt, C, Hoffmann, S, Bestle, MH , Gyldensted, L, Nebrich, L, Russell, L, Vang, M, Sølling, C, Brøchner, AC, Rasmussen, BS & Perner, A 2020, 'Long-term patient-important outcomes after septic shock: a protocol for 1-year follow-up of the CLASSIC-trial', Acta Anaesthesiologica Scandinavica, vol. 64, no. 3, pp. 410–416. https://doi.org/10.1111/aas.13519

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title = "Long-term patient-important outcomes after septic shock: a protocol for 1-year follow-up of the CLASSIC-trial",

abstract = "BACKGROUND: In patients with septic shock, mortality is high, and survivors experience long-term physical, mental and social impairments. The ongoing Conservative vs Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial assesses the benefits and harms of a restrictive vs standard-care intravenous (IV) fluid therapy. The hypothesis is that IV fluid restriction improves patient-important long-term outcomes.AIM: To assess the predefined patient-important long-term outcomes in patients randomised into the CLASSIC trial.METHODS: In this pre-planned follow-up study of the CLASSIC trial, we will assess all-cause mortality, health-related quality of life (HRQoL) and cognitive function 1 year after randomisation in the two intervention groups. The 1-year mortality will be collected from electronic patient records or central national registries in most participating countries. We will contact survivors and assess EuroQol 5-Dimension, -5-Level (EQ-5D-5L) and EuroQol-Visual Analogue Scale and Montreal Cognitive Assessment 5-minute protocol score. We will analyse mortality by logistic regression and use general linear models to assess HRQoL and cognitive function.DISCUSSION: With this pre-planned follow-up study of the CLASSIC trial, we will provide patient-important data on long-term survival, HRQoL and cognitive function of restrictive vs standard-care IV fluid therapy in patients with septic shock.",

keywords = "cognitive function, follow-up, HRQoL, IV fluid therapy, patient important outcomes, randomised clincial trial",

author = "Kjaer, {Maj-Brit N{\o}rregaard} and Meyhoff, {Tine Sylvest} and Madsen, {Martin Bruun} and Hjortrup, {Peter Buhl} 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 Ville Pettil{\"a} and {van der Horst}, {Iwan C C} and Marlies Ostermann and Paul Mouncey and Maurizio Cecconi and Ricard Ferrer and {L N G Malbrain}, Manu and Christian Ahlstedt and S{\o}ren Hoffmann and Bestle, {Morten H} and Louise Gyldensted and Lars Nebrich and Lene Russell and Marianne Vang and Christoffer S{\o}lling and Br{\o}chner, {Anne Craveiro} and Rasmussen, {Bodil Steen} and Anders Perner",

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year = "2020",

month = mar,

doi = "10.1111/aas.13519",

language = "English",

volume = "64",

pages = "410–416",

journal = "Acta Anaesthesiologica Scandinavica",

issn = "0001-5172",

publisher = "Wiley-Blackwell Munksgaard",

number = "3",

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TY - JOUR

T1 - Long-term patient-important outcomes after septic shock

T2 - a protocol for 1-year follow-up of the CLASSIC-trial

AU - Kjaer, Maj-Brit Nørregaard

AU - Meyhoff, Tine Sylvest

AU - Madsen, Martin Bruun

AU - Hjortrup, Peter Buhl

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 - Pettilä, Ville

AU - van der Horst, Iwan C C

AU - Ostermann, Marlies

AU - Mouncey, Paul

AU - Cecconi, Maurizio

AU - Ferrer, Ricard

AU - L N G Malbrain, Manu

AU - Ahlstedt, Christian

AU - Hoffmann, Søren

AU - Bestle, Morten H

AU - Gyldensted, Louise

AU - Nebrich, Lars

AU - Russell, Lene

AU - Vang, Marianne

AU - Sølling, Christoffer

AU - Brøchner, Anne Craveiro

AU - Rasmussen, Bodil Steen

AU - Perner, Anders

PY - 2020/3

Y1 - 2020/3

N2 - BACKGROUND: In patients with septic shock, mortality is high, and survivors experience long-term physical, mental and social impairments. The ongoing Conservative vs Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial assesses the benefits and harms of a restrictive vs standard-care intravenous (IV) fluid therapy. The hypothesis is that IV fluid restriction improves patient-important long-term outcomes.AIM: To assess the predefined patient-important long-term outcomes in patients randomised into the CLASSIC trial.METHODS: In this pre-planned follow-up study of the CLASSIC trial, we will assess all-cause mortality, health-related quality of life (HRQoL) and cognitive function 1 year after randomisation in the two intervention groups. The 1-year mortality will be collected from electronic patient records or central national registries in most participating countries. We will contact survivors and assess EuroQol 5-Dimension, -5-Level (EQ-5D-5L) and EuroQol-Visual Analogue Scale and Montreal Cognitive Assessment 5-minute protocol score. We will analyse mortality by logistic regression and use general linear models to assess HRQoL and cognitive function.DISCUSSION: With this pre-planned follow-up study of the CLASSIC trial, we will provide patient-important data on long-term survival, HRQoL and cognitive function of restrictive vs standard-care IV fluid therapy in patients with septic shock.

AB - BACKGROUND: In patients with septic shock, mortality is high, and survivors experience long-term physical, mental and social impairments. The ongoing Conservative vs Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial assesses the benefits and harms of a restrictive vs standard-care intravenous (IV) fluid therapy. The hypothesis is that IV fluid restriction improves patient-important long-term outcomes.AIM: To assess the predefined patient-important long-term outcomes in patients randomised into the CLASSIC trial.METHODS: In this pre-planned follow-up study of the CLASSIC trial, we will assess all-cause mortality, health-related quality of life (HRQoL) and cognitive function 1 year after randomisation in the two intervention groups. The 1-year mortality will be collected from electronic patient records or central national registries in most participating countries. We will contact survivors and assess EuroQol 5-Dimension, -5-Level (EQ-5D-5L) and EuroQol-Visual Analogue Scale and Montreal Cognitive Assessment 5-minute protocol score. We will analyse mortality by logistic regression and use general linear models to assess HRQoL and cognitive function.DISCUSSION: With this pre-planned follow-up study of the CLASSIC trial, we will provide patient-important data on long-term survival, HRQoL and cognitive function of restrictive vs standard-care IV fluid therapy in patients with septic shock.

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KW - follow-up

KW - HRQoL

KW - IV fluid therapy

KW - patient important outcomes

KW - randomised clincial trial

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U2 - 10.1111/aas.13519

DO - 10.1111/aas.13519

M3 - Journal article

C2 - 31828753

SN - 0001-5172

VL - 64

SP - 410

EP - 416

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

IS - 3

ER -

Long-term patient-important outcomes after septic shock: a protocol for 1-year follow-up of the CLASSIC-trial

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