Hemoadsorption with CytoSorb shows a decreased observed versus expected 28-day all-cause mortality in ICU patients with septic shock: a propensity-score-weighted retrospective study

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Abstract

Background and aims

Innovative treatment modalities have not yet shown a clinical benefit in patients with septic shock. To reduce severe cytokinaemia, CytoSorb as an add-on to continuous renal replacement therapy (CRRT) showed promising results in case reports. However, there are no clinical trials investigating outcomes.

Methods

In this investigator-initiated retrospective study, patients with septic shock were treated with CRRT + CytoSorb ( n = 67) or CRRT alone ( n = 49). The primary outcome was the 28-day all-cause mortality rate. Patients were weighted by stabilized inverse probability of treatment weights (sIPTW) to overcome differences in baseline characteristics.

Results

At the start of therapy, CytoSorb-treated patients had higher lactate levels ( p < 0.001), lower mean arterial pressure ( p = 0.007) and higher levels of noradrenaline ( p < 0.001) compared to the CRRT group. For CytoSorb, the mean predicted mortality rate based on a SOFA of 13.8 ( n = 67) was 75% (95%CI 71–79%), while the actual 28-day mortality rate was 48% (mean difference − 27%, 95%CI − 38 to − 15%, p < 0.001). For CRRT, based on a SOFA of 12.8 ( n = 49), the mean predicted versus observed mortality was 68% versus 51% (mean difference − 16.9% [95%CI − 32.6 to − 1.2%, p = 0.035]). By sIPTW analysis, patients treated with CytoSorb had a significantly lower 28-day mortality rate compared to CRRT alone (53% vs. 72%, respectively, p = 0.038). Independent predictors of 28-day mortality in the CytoSorb group were the presence of pneumosepsis (adjusted odds ratio [aOR] 5.47, p = 0.029), higher levels of lactate at the start of CytoSorb (aOR 1.15, p = 0.031) and older age (aOR per 10 years 1.67, p = 0.034).

Conclusions

CytoSorb was associated with a decreased observed versus expected 28-day all-cause mortality. By IPTW analysis, intervention with CytoSorb may be associated with a decreased all-cause mortality at 28 days compared to CRRT alone.

Electronic supplementary material

The online version of this article (10.1186/s13054-019-2588-1) contains supplementary material, which is available to authorized users.

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Most cited references 21

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Propensity score techniques and the assessment of measured covariate balance to test causal associations in psychological research.

Daniel C. Anthony, S Harder, Philip Stuart (2010)

There is considerable interest in using propensity score (PS) statistical techniques to address questions of causal inference in psychological research. Many PS techniques exist, yet few guidelines are available to aid applied researchers in their understanding, use, and evaluation. In this study, the authors give an overview of available techniques for PS estimation and PS application. They also provide a way to help compare PS techniques, using the resulting measured covariate balance as the criterion for selecting between techniques. The empirical example for this study involves the potential causal relationship linking early-onset cannabis problems and subsequent negative mental health outcomes and uses data from a prospective cohort study. PS techniques are described and evaluated on the basis of their ability to balance the distributions of measured potentially confounding covariates for individuals with and without early-onset cannabis problems. This article identifies the PS techniques that yield good statistical balance of the chosen measured covariates within the context of this particular research question and cohort.

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Outcomes of the Surviving Sepsis Campaign in intensive care units in the USA and Europe: a prospective cohort study.

Andrew Rhodes, Richard Beale, John G. Phillips … (2012)

Mortality from severe sepsis and septic shock differs across continents, countries, and regions. We aimed to use data from the Surviving Sepsis Campaign (SSC) to compare models of care and outcomes for patients with severe sepsis and septic shock in the USA and Europe. The SSC was introduced into more than 200 sites in Europe and the USA. All patients identified with severe sepsis and septic shock in emergency departments or hospital wards and admitted to intensive care units (ICUs), and those with sepsis in ICUs were entered into the SSC database. Patients entered into the database from its launch in January, 2005, through January, 2010, in units with at least 20 patients and 3 months of enrolment of patients were included in this analysis. Patients included in the cohort were limited to those entered in the first 4 years at every site. We used random-effects logistic regression to estimate the hospital mortality odds ratio (OR) for Europe relative to the USA. We used random-effects linear regression to find the relation between lengths of stay in hospital and ICU and geographic region. 25 375 patients were included in the cohort. The USA included 107 sites with 18 766 (74%) patients, and Europe included 79 hospital sites with 6609 (26%) patients. In the USA, 12 218 (65·1%) were admitted to the ICU from the emergency department whereas in Europe, 3405 (51·5%) were admitted from the wards. The median stay on the hospital wards before ICU admission was longer in Europe than in the USA (1·0 vs 0·1 days, difference 0·9, 95% CI 0·8-0·9). Raw hospital mortality was higher in Europe than in the USA (41·1%vs 28·3%, difference 12·8, 95% CI 11·5-14·7). The median length of stay in ICU (7·8 vs 4·2 days, 3·6, 3·3-3·7) and hospital (22·8 vs 10·5 days, 12·3, 11·9-12·8) was longer in Europe than in the USA. Adjusted mortality in Europe was not significantly higher than that in the USA (32·3%vs 31·3%, 1·0, -1·7 to 3·7, p=0·468). Complete compliance with all applicable elements of the sepsis resuscitation bundle was higher in the USA than in Europe (21·6%vs 18·4%, 3·2, 2·2-4·4). The significant difference in unadjusted mortality and the fact that this difference disappears with severity adjustment raise important questions about the effect of the approach to critical care in Europe compared with that in the USA. The effect of ICU bed availability on outcomes in patients with severe sepsis and septic shock requires further investigation. Copyright © 2012 Elsevier Ltd. All rights reserved.

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The effect of a novel extracorporeal cytokine hemoadsorption device on IL-6 elimination in septic patients: A randomized controlled trial

Dirk Schädler, Christine Pausch, Daniel Heise … (2017)

Objective We report on the effect of hemoadsorption therapy to reduce cytokines in septic patients with respiratory failure. Methods This was a randomized, controlled, open-label, multicenter trial. Mechanically ventilated patients with severe sepsis or septic shock and acute lung injury or acute respiratory distress syndrome were eligible for study inclusion. Patients were randomly assigned to either therapy with CytoSorb hemoperfusion for 6 hours per day for up to 7 consecutive days (treatment), or no hemoperfusion (control). Primary outcome was change in normalized IL-6-serum concentrations during study day 1 and 7. Results 97 of the 100 randomized patients were analyzed. We were not able to detect differences in systemic plasma IL-6 levels between the two groups (n = 75; p = 0.15). Significant IL-6 elimination, averaging between 5 and 18% per blood pass throughout the entire treatment period was recorded. In the unadjusted analysis, 60-day-mortality was significantly higher in the treatment group (44.7%) compared to the control group (26.0%; p = 0.039). The proportion of patients receiving renal replacement therapy at the time of enrollment was higher in the treatment group (31.9%) when compared to the control group (16.3%). After adjustment for patient morbidity and baseline imbalances, no association of hemoperfusion with mortality was found (p = 0.19). Conclusions In this patient population with predominantly septic shock and multiple organ failure, hemoadsorption removed IL-6 but this did not lead to lower plasma IL-6-levels. We did not detect statistically significant differences in the secondary outcomes multiple organ dysfunction score, ventilation time and time course of oxygenation.

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Author and article information

Contributors

Willem Pieter Brouwer:

ORCID: http://orcid.org/0000-0001-8713-1481

w.p.brouwer@erasmusmc.nl

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): 18 September 2019

Publication date PMC-release: 18 September 2019

Publication date Collection: 2019

Volume: 23

Electronic Location Identifier: 317

Affiliations

[1 ]ISNI 000000040459992X, GRID grid.5645.2, Department of Gastroenterology and Hepatology, , Erasmus MC, University Medical Center Rotterdam, ; Dr Molewaterplein 15, Building NA-6, 3015 CE Rotterdam, The Netherlands

[2 ]ISNI 0000 0004 0460 0556, GRID grid.416213.3, Department of Internal Medicine, , Maasstad Ziekenhuis, ; Rotterdam, The Netherlands

[3 ]ISNI 0000 0004 0460 0556, GRID grid.416213.3, Department of Intensive Care Medicine, , Maasstad Ziekenhuis, ; Rotterdam, The Netherlands

[4 ]ISNI 0000 0004 0460 0556, GRID grid.416213.3, Science board, , Maasstad Ziekenhuis, ; Rotterdam, The Netherlands

[5 ]ISNI 000000040459992X, GRID grid.5645.2, Department of Intensive Care Medicine, , Erasmus MC, University Medical Center Rotterdam, ; Rotterdam, The Netherlands

Author information

Willem Pieter Brouwer http://orcid.org/0000-0001-8713-1481

Article

Publisher ID: 2588

DOI: 10.1186/s13054-019-2588-1

PMC ID: 6749645

PubMed ID: 31533846

SO-VID: 994e34f0-ace5-4017-aa11-1ff12b6b0292

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 : 16 June 2019

Date accepted : 28 August 2019

Custom metadata

ScienceOpen disciplines: Emergency medicine & Trauma

Keywords: sepsis,septic shock,treatment,hemofiltration,cytosorb,cytosorbent,mortality,outcome

Data availability:

ScienceOpen disciplines: Emergency medicine & Trauma

Keywords: sepsis, septic shock, treatment, hemofiltration, cytosorb, cytosorbent, mortality, outcome

Hemoadsorption with CytoSorb shows a decreased observed versus expected 28-day all-cause mortality in ICU patients with septic shock: a propensity-score-weighted retrospective study

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Abstract

Background and aims

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Electronic supplementary material

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Irish Journal of Paramedicine

Most cited references 21

Propensity score techniques and the assessment of measured covariate balance to test causal associations in psychological research.

Outcomes of the Surviving Sepsis Campaign in intensive care units in the USA and Europe: a prospective cohort study.

The effect of a novel extracorporeal cytokine hemoadsorption device on IL-6 elimination in septic patients: A randomized controlled trial

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