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

Maj-Brit N Kjaer; Tine S Meyhoff; Martin B Madsen; Peter B Hjortrup; Morten Hylander Møller; Ingrid Egerod; Jørn Wetterslev; Theis Lange; Maria Cronhjort; Jon H 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 C Brøchner; Bodil S 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 N Kjaer, Tine S Meyhoff, Martin B Madsen, Peter B Hjortrup, Morten Hylander Møller, Ingrid Egerod, Jørn Wetterslev, Theis Lange, Maria Cronhjort, Jon H 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 C Brøchner, Bodil S Rasmussen, Anders Perner

Research output: Contribution to journal › Article › peer-review

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
Pages (from-to)	410-416
Number of pages	7
Journal	Acta Anaesthesiologica Scandinavica
Volume	64
Issue number	3
DOIs	https://doi.org/10.1111/aas.13519
Publication status	Published - 1 Mar 2020

Bibliographical note

Keywords

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

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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., Malbrain, M. L. N. G., ... 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

@article{988e745bf07e40828ba405abaae7f6d7,

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

author = "Kjaer, {Maj-Brit N} and Meyhoff, {Tine S} and Madsen, {Martin B} and Hjortrup, {Peter B} and M{\o}ller, {Morten Hylander} and Ingrid Egerod and J{\o}rn Wetterslev and Theis Lange and Maria Cronhjort and Laake, {Jon H} 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 Malbrain, {Manu L N G} 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 C} and Rasmussen, {Bodil S} and Anders Perner",

note = "{\textcopyright} 2019 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.",

year = "2020",

month = mar,

day = "1",

doi = "10.1111/aas.13519",

language = "English",

volume = "64",

pages = "410--416",

journal = "Acta Anaesthesiologica Scandinavica",

issn = "0001-5172",

publisher = "Blackwell Munksgaard",

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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, Malbrain, MLNG, 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

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 N

AU - Meyhoff, Tine S

AU - Madsen, Martin B

AU - Hjortrup, Peter B

AU - Møller, Morten Hylander

AU - Egerod, Ingrid

AU - Wetterslev, Jørn

AU - Lange, Theis

AU - Cronhjort, Maria

AU - Laake, Jon H

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 - Malbrain, Manu L N G

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 C

AU - Rasmussen, Bodil S

AU - Perner, Anders

PY - 2020/3/1

Y1 - 2020/3/1

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.

KW - HRQoL

KW - IV fluid therapy

KW - cognitive function

KW - follow-up

KW - patient important outcomes

KW - randomised clincial trial

UR - http://www.scopus.com/inward/record.url?scp=85077386485&partnerID=8YFLogxK

U2 - 10.1111/aas.13519

DO - 10.1111/aas.13519

M3 - 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

Abstract

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