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Long-Term Quality of Life Among Survivors of Severe Sepsis: Analyses of Two International Trials*

Yende, Sachin MD, MS; Austin, Shamly PhD, MHA; Rhodes, Andrew MD; Finfer, Simon MD, FCICM; Opal, Steven MD; Thompson, Taylor MD; Bozza, Fernando A. MD, PhD; LaRosa, Steven P. MD; Ranieri, V. Marco MD; Angus, Derek C. MD, MPH

doi: 10.1097/CCM.0000000000001658
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Objectives: To describe the quality of life among sepsis survivors.

Design: Secondary analyses of two international, randomized clinical trials (A Controlled Comparison of Eritoran and placebo in patients with Severe Sepsis [derivation cohort] and PROWESS-SHOCK [validation cohort]).

Setting: ICUs in North and South America, Europe, Africa, Asia, and Australia.

Patients: Adults with severe sepsis. We analyzed only patients who were functional and living at home without help before sepsis hospitalization (n = 1,143 and 987 from A Controlled Comparison of Eritoran and placebo in patients with Severe Sepsis and PROWESS-SHOCK, respectively).

Interventions: None.

Measurements and Main Results: In A Controlled Comparison of Eritoran and placebo in patients with Severe Sepsis and PROWESS-SHOCK, the average age of patients living at home independently was 63 and 61 years; 400 (34.9%) and 298 (30.2%) died by 6 months. In A Controlled Comparison of Eritoran and placebo in patients with Severe Sepsis, 580 patients had a quality of life measured using EQ-5D at 6 months. Of these, 41.6% could not live independently (22.7% were home but required help, 5.1% were in nursing home or rehabilitation facilities, and 5.3% were in acute care hospitals). Poor quality of life at 6 months, as evidenced by problems in mobility, usual activities, and self-care domains were reported in 37.4%, 43.7%, and 20.5%, respectively, and the high incidence of poor quality of life was also seen in patients in PROWESS-SHOCK. Over 45% of patients with mobility and self-care problems at 6 months in A Controlled Comparison of Eritoran and placebo in patients with Severe Sepsis died or reported persistent problems at 1 year.

Conclusions: Among individuals enrolled in a clinical trial who lived independently prior to severe sepsis, one third had died and of those who survived, a further one third had not returned to independent living by 6 months. Both mortality and quality of life should be considered when designing new interventions and considering endpoints for sepsis trials.

1The Clinical Research, Investigation, and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA.

2Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, PA.

3Research and Development, Quality Improvement Department, Gateway Health, Pittsburgh, PA.

4Adult Critical Care, St. George’s University Hospitals, NHS Foundation Trust, London, United Kingdom.

5The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia.

6Infectious Disease Division, Alpert Medical School of Brown University, Pawtucket, RI.

7Pulmonary and Critical Care Division, Massachusetts General Hospital, Boston, MA.

8Evandro Chagas National Institute of Infectious Diseases, Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, Brazil.

9Beverly Hospital, Lahey Health System, Beverly, MA.

10Department of Anesthesia and Intensive Care Medicine, University Sapienza of Rome, Policlino Umberto I Hospital, Rome, Italy.

*See also p. 1603.

The contents of this article do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://journals.lww.com/ccmjournal).

Dr. Rhodes consulted for, received support for travel from, and received support for participation in review activities from Eli Lilly (Dr. Rhodes was paid by Eli Lilly to act on the SSC of the PROWESS-SHOCK Trial). He lectured for LiDCO (lecture fees). Dr. Opal’s institution received funding from Eisai (provided a grant to institution to run the clinical coordinating center for the phase 3 study of Eritoran), Ferring (for clinical coordinating center), and Cardeas. He disclosed other support from Arsanis (advisory committee), Aridis (consultant), BioAegis (consultant), Glaxo Smith Kline (institutional grant), Atoxbio (institutional grant), Immunexpress (consultant), Battelle (consultant), Bekton-Dickenson (consultant), and Spectral, Partek, and Achaogen (data monitoring board). Dr. Thompson consulted for Lilly (see electronic supplement to PMID: 22616830 for details) and received support for travel from Lilly. Dr. Bozza is employed by Oswaldo Cruz Foundation, Ministry of Health, Brazil. Dr. Bozza and his institution received grant support from CNPq, FAPERJ, CAPES (Brazilian Agencies for Research), the National Institutes of Health, Wellcome Trust, and Biomerieux Foundation. Dr. LaRosa received support for participation in review activities from Easai (clinical evaluation committee—A Controlled Comparison of Eritoran and placebo in patients with Severe Sepsis [ACCESS] trial) and consulted (scientific advisory board). His institution received grant support from Easai (for access trial). Dr. Angus served as a board member for data and safety monitoring board PROWESS-SHOCK Trial and consulted for Eisai for ACCESS, Ferring Pharmaceuticals, Medimmune, and GlaxoSmithKline. He received grant support from Eisai. The remaining authors have disclosed that they do not have any potential conflicts of interest.

For information regarding this article, E-mail: yendes@upmc.edu

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