The early change of SOFA score as a prognostic marker of 28-day sepsis mortality: analysis through a derivation and a validation cohort

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Abstract

Background

Since the Sepsis-3 criteria, change in Sequential Organ Failure Assessment (SOFA) score has become a key component of sepsis identification. Thus, it could be argued that reversal of this change (Δ _SOFA) may reflect sepsis response and could be used as measure of efficacy in interventional trials. We aimed to assess the predictive performance of Δ _SOFA for 28-day mortality.

Methods

Data from two previously published randomized controlled trials were studied: the first reporting on patients with severe Gram-negative infections as a derivation cohort and the second reporting on patients with ventilator-associated pneumonia as a validation cohort. Only patients with sepsis according to the Sepsis-3 definition were included in this analysis. SOFA scores were calculated on days 1, 2, 3, 5, 7, 14, and 28.

Results

We included 448 patients within the derivation cohort and 199 within the validation cohort. Mean SOFA scores on day 1 were 6.06 ± 4.07 and 7.84 ± 3.39, and 28 day mortality 22.8% and 29.6%, respectively. In the derivation cohort, the earliest time point where Δ _SOFA score predicted mortality was day 7 (AUROC (95% CI) 0.84 (0.80–0.89); p < 0.001). The best tradeoff for prediction was found with 25% changes (78% sensitivity, 80% specificity); less than 25% decrease of admission SOFA was associated with increased mortality (odds ratio for death 14.87). This finding was confirmed in the validation cohort.

Conclusions

Δ _SOFA on day 7 is a useful early prognostic marker of 28-day mortality and could serve as an endpoint in future sepsis trials alongside mortality.

Trial registration

ClinicalTrials.gov numbers NCT01223690 and NCT00297674

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Most cited references 8

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Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter randomized control trial

Didier M. Payen, Joëlle Guilhot, Yoann Launey … (2015)

Purpose To test whether the polymyxin B hemoperfusion (PMX HP) fiber column reduces mortality and organ failure in peritonitis-induced septic shock (SS) from abdominal infections. Method Prospective, multicenter, randomized controlled trial in 18 French intensive care units from October 2010 to March 2013, enrolling 243 patients with SS within 12 h after emergency surgery for peritonitis related to organ perforation. The PMX HP group received conventional therapy plus two sessions of PMX HP. Primary outcome was mortality on day 28; secondary outcomes were mortality on day 90 and a reduction in the severity of organ failures based on Sequential Organ Failure Assessment (SOFA) scores. Results Primary outcome: day 28 mortality in the PMX HP group (n = 119) was 27.7 versus 19.5 % in the conventional group (n = 113), p = 0.14 (OR 1.5872, 95 % CI 0.8583–2.935). Secondary endpoints: mortality rate at day 90 was 33.6 % in PMX-HP versus 24 % in conventional groups, p = 0.10 (OR 1.6128, 95 % CI 0.9067–2.8685); reduction in SOFA score from day 0 to day 7 was −5 (−11 to 6) in PMX-HP versus −5 (−11 to 9), p = 0.78. Comparable results were observed in the predefined subgroups (presence of comorbidity; adequacy of surgery, <2 sessions of hemoperfusion) and for SOFA reduction from day 0 to day 3. Conclusion This multicenter randomized controlled study demonstrated a non-significant increase in mortality and no improvement in organ failure with PMX HP treatment compared to conventional treatment of peritonitis-induced SS. Electronic supplementary material The online version of this article (doi:10.1007/s00134-015-3751-z) contains supplementary material, which is available to authorized users.

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Late mortality after sepsis: propensity matched cohort study

Hallie C Prescott, John Osterholzer, Kenneth M Langa … (2016)

Objectives To determine whether late mortality after sepsis is driven predominantly by pre-existing comorbid disease or is the result of sepsis itself. Deign Observational cohort study. Setting US Health and Retirement Study. Participants 960 patients aged ≥65 (1998-2010) with fee-for-service Medicare coverage who were admitted to hospital with sepsis. Patients were matched to 777 adults not currently in hospital, 788 patients admitted with non-sepsis infection, and 504 patients admitted with acute sterile inflammatory conditions. Main outcome measures Late (31 days to two years) mortality and odds of death at various intervals. Results Sepsis was associated with a 22.1% (95% confidence interval 17.5% to 26.7%) absolute increase in late mortality relative to adults not in hospital, a 10.4% (5.4% to 15.4%) absolute increase relative to patients admitted with non-sepsis infection, and a 16.2% (10.2% to 22.2%) absolute increase relative to patients admitted with sterile inflammatory conditions (P<0.001 for each comparison). Mortality remained higher for at least two years relative to adults not in hospital. Conclusions More than one in five patients who survives sepsis has a late death not explained by health status before sepsis.

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SOFA and mortality endpoints in randomized controlled trials: a systematic review and meta-regression analysis

Harm-Jan S. de Grooth, Irma Geenen, Armand R J Girbes … (2017)

Background The sequential organ failure assessment score (SOFA) is increasingly used as an endpoint in intensive care randomized controlled trials (RCTs). Although serially measured SOFA is independently associated with mortality in observational cohorts, the association between treatment effects on SOFA vs. effects on mortality has not yet been quantified in RCTs. The aim of this study was to quantify the relationship between SOFA and mortality in RCTs and to identify which SOFA derivative best reflects between-group mortality differences. Methods The review protocol was prospectively registered (Prospero CRD42016034014). We performed a literature search (up to May 1, 2016) for RCTs reporting both SOFA and mortality, and analyzed between-group differences in these outcomes. Treatment effects on SOFA and mortality were calculated as the between-group SOFA standardized difference and log odds ratio (OR), respectively. We used random-effects meta-regression to (1) quantify the linear relationship between RCT treatment effects on mortality (logOR) and SOFA (i.e. responsiveness) and (2) quantify residual heterogeneity (i.e. consistency, expressed as I 2). Results Of 110 eligible RCTs, 87 qualified for analysis. Using all RCTs, SOFA was significantly associated with mortality (slope = 0.49 (95% CI 0.17; 0.82), p = 0.006, I 2 = 5%); the overall mortality effect explained by SOFA score (R 2) was 9%. Fifty-eight RCTs used Fixed-day SOFA as an endpoint (i.e. the score on a fixed day after randomization), 25 studies used Delta SOFA as an endpoint (i.e. the trajectory from baseline score) and 15 studies used other SOFA derivatives as an endpoint. Fixed-day SOFA was not significantly associated with mortality (slope = 0.35 (95% CI −0.04; 0.75), p = 0.08, I 2 = 12%) and explained 3% of the overall mortality effect (R 2). Delta SOFA was significantly associated with mortality (slope = 0.70 (95% CI 0.26; 1.14), p = 0.004, I 2 = 0%) and explained 32% of the overall mortality effect (R 2). Conclusions Treatment effects on Delta SOFA appear to be reliably and consistently associated with mortality in RCTs. Fixed-day SOFA was the most frequently reported outcome among the reviewed RCTs, but was not significantly associated with mortality. Based on this study, we recommend using Delta SOFA rather than Fixed-day SOFA as an endpoint in future RCTs. Electronic supplementary material The online version of this article (doi:10.1186/s13054-017-1609-1) contains supplementary material, which is available to authorized users.

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Author and article information

Contributors

Eleni Karakike: elkarakike@gmail.com

Evdoxia Kyriazopoulou: ekyriazopoulou@windowslive.com

Iraklis Tsangaris: itsagkaris@med.uoa.gr

Christina Routsi: chroutsi@hotmail.com

Jean-Louis Vincent: jlvincent@ulb.ac.be

Evangelos J. Giamarellos-Bourboulis:

ORCID: http://orcid.org/0000-0003-4713-3911

+30 210 58 31 994 , egiamarel@med.uoa.gr

Journal

Journal ID (nlm-ta): Crit Care

Title: Critical Care

Publisher: BioMed Central (London )

ISSN (Print): 1364-8535

ISSN (Electronic): 1466-609X

Publication date (Electronic): 29 November 2019

Publication date PMC-release: 29 November 2019

Publication date Collection: 2019

Volume: 23

Electronic Location Identifier: 387

Affiliations

[1 ]ISNI 0000 0001 2155 0800, GRID grid.5216.0, 4th Department of Internal Medicine, Attikon University Hospital, , National and Kapodistrian University of Athens, ; 1 Rimini Street, 12462 Athens, Greece

[2 ]ISNI 0000 0001 2155 0800, GRID grid.5216.0, 2nd Department of Critical Care Medicine, , National and Kapodistrian University of Athens, ; 12462 Athens, Greece

[3 ]ISNI 0000 0001 2155 0800, GRID grid.5216.0, 1st Department of Critical Care Medicine, , National and Kapodistrian University of Athens, ; 10676 Athens, Greece

[4 ]ISNI 0000 0001 2348 0746, GRID grid.4989.c, Department of Intensive Care, Erasme Hospital, , Université libre de Bruxelles, ; 1070 Brussels, Belgium

Author information

Evangelos J. Giamarellos-Bourboulis http://orcid.org/0000-0003-4713-3911

Article

Publisher ID: 2665

DOI: 10.1186/s13054-019-2665-5

PMC ID: 6884794

PubMed ID: 31783881

SO-VID: a7ecca15-0b62-4529-9ff2-744943b72d01

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 17 July 2019

Date accepted : 7 November 2019

Funding

Funded by: Hellenic Institute for the Study of Sepsis

Custom metadata

ScienceOpen disciplines: Emergency medicine & Trauma

Keywords: sequential organ failure assessment (sofa),delta change,sepsis,mortality,trial endpoints

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ScienceOpen disciplines: Emergency medicine & Trauma

Keywords: sequential organ failure assessment (sofa), delta change, sepsis, mortality, trial endpoints

The early change of SOFA score as a prognostic marker of 28-day sepsis mortality: analysis through a derivation and a validation cohort

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Abstract

Background

Methods

Results

Conclusions

Trial registration

Related collections

Irish Journal of Paramedicine

Most cited references 8

Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter randomized control trial

Late mortality after sepsis: propensity matched cohort study

SOFA and mortality endpoints in randomized controlled trials: a systematic review and meta-regression analysis

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