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Does a program to increase intensive care unit (ICU) admission rates among critically ill elderly patients have a beneficial effect on long-term outcomes?
In this cluster-randomized clinical trial of 3036 critically ill patients aged 75 years or older, a recommendation for systematic ICU admission led to a significantly higher ICU admission rate but had no significant effect on mortality at 6 months vs standard practice (adjusted relative risk, 1.05).
A program to promote systematic ICU admission among critically ill elderly patients increased ICU use but did not reduce 6-month mortality.
The high mortality rate in critically ill elderly patients has led to questioning of the beneficial effect of intensive care unit (ICU) admission and to a variable ICU use among this population.
To determine whether a recommendation for systematic ICU admission in critically ill elderly patients reduces 6-month mortality compared with usual practice.
Design, Setting, and Participants
Multicenter, cluster-randomized clinical trial of 3037 critically ill patients aged 75 years or older, free of cancer, with preserved functional status (Index of Independence in Activities of Daily Living ≥4) and nutritional status (absence of cachexia) who arrived at the emergency department of one of 24 hospitals in France between January 2012 and April 2015 and were followed up until November 2015.
Centers were randomly assigned either to use a program to promote systematic ICU admission of patients (n=1519 participants) or to follow standard practice (n=1518 participants).
Main Outcomes and Measures
The primary outcome was death at 6 months. Secondary outcomes included ICU admission rate, in-hospital death, functional status, and quality of life (12-Item Short Form Health Survey, ranging from 0 to 100, with higher score representing better self-reported health) at 6 months.
One patient withdrew consent, leaving 3036 patients included in the trial (median age, 85 [interquartile range, 81-89] years; 1361 [45%] men). Patients in the systematic strategy group had an increased risk of death at 6 months (45% vs 39%; relative risk [RR], 1.16; 95% CI, 1.07-1.26) despite an increased ICU admission rate (61% vs 34%; RR, 1.80; 95% CI, 1.66-1.95). After adjustments for baseline characteristics, patients in the systematic strategy group were more likely to be admitted to an ICU (RR, 1.68; 95% CI, 1.54-1.82) and had a higher risk of in-hospital death (RR, 1.18; 95% CI, 1.03-1.33) but had no significant increase in risk of death at 6 months (RR, 1.05; 95% CI, 0.96-1.14). Functional status and physical quality of life at 6 months were not significantly different between groups.
Conclusions and Relevance
Among critically ill elderly patients in France, a program to promote systematic ICU admission increased ICU use but did not reduce 6-month mortality. Additional research is needed to understand the decision to admit elderly patients to the ICU.
clinicaltrials.gov Identifier: NCT01508819
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Corresponding Author: Bertrand Guidet, MD, Medical Intensive Care Unit, Saint-Antoine Hospital, 184, rue du Faubourg Saint-Antoine, Paris, 75012, France (email@example.com).
Accepted for Publication: August 29, 2017.
Published Online: September 27, 2017. doi:10.1001/jama.2017.13889
Author Contributions: Dr Boumendil had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Guidet, Simon, Garrouste-Orgeas, Thomas, Pateron, Boumendil.
Acquisition, analysis, or interpretation of data: Guidet, Leblanc, Woimant, Quenot, Ganansia, Maignan, Yordanov, Delerme, Doumenc, Fartoukh, Charestan, Trognon, Galichon, Javaud, Patzak, Azerad, Boumendil.
Drafting of the manuscript: Guidet, Leblanc, Thomas, Boumendil.
Critical revision of the manuscript for important intellectual content: Guidet, Leblanc, Simon, Woimant, Quenot, Ganansia, Maignan, Yordanov, Delerme, Doumenc, Fartoukh, Charestan, Trognon, Galichon, Javaud, Patzak, Garrouste-Orgeas, Thomas, Azerad, Pateron, Boumendil.
Statistical analysis: Guidet, Leblanc, Boumendil.
Obtained funding: Guidet, Simon, Boumendil.
Administrative, technical, or material support: Simon, Quenot, Ganansia, Maignan, Yordanov, Javaud, Thomas, Azerad.
Supervision: Guidet, Simon, Garrouste-Orgeas, Thomas, Pateron, Boumendil.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Guidet reports receipt of lecture fees from Griffols and LFB and grants from LFB. Dr Simon reports receipt of grants from AstraZeneca, Daiichi-Sankyo, Lilly, GlaxoSmithKline, Merck Sharpe and Dohme, Novartis, and Sanofi and board membership, consultancy, or lecture fees from AstraZeneca, Astellas, Merck Sharpe and Dohme, Novartis, and Sanofi. No other disclosures were reported.
Funding/Support: This study was supported by Assistance Publique–Hôpitaux de Paris, Département de la Recherche Clinique et du Développement (project code K100103/IDRCB 2011-A00758-33). The study was funded by the Programme Hospitalier de Recherche Clinique 2010 of the French Ministry of Health and (grant PHRC 2010 AOM 10154 K100103).
Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Group Information: ICE-CUB 2 Study Network: Bertrand Guidet, MD, Dominique Pateron, MD, Erwan Debuc, MD, Youri Yordanov, MD (top 10 recruiter), Ariane Boumendil, PhD, Caroline Thomas, MD; Didier Dreyfuss, MD, Jean-Damien Ricard, MD, PhD, Patrick Brun, MD, Christophe Leroy, MD, Yves Cohen, MD, Frédéric Adnet, MD, PhD, Maguy Woimant, MD (top 10 recruiter), Jean-Paul Mira, MD, PhD, Benoît Doumenc, MD (top 10 recruiter), Khalil Tku, MD; Thomas Similowski, MD, PhD, Bruno Riou, MD, PhD, Pierre Hausfater, MD, PhD, Samuel Delerme, MD (top 10 recruiter), Jean-Pierre Quenot, MD, PhD (top 10 recruiter), Didier Honnart, MD, Jean-François Timsit, MD, PhD, Pierrick Guérin, MD, Françoise Carpentier, MD, Maxime Maignan, MD (top 10 recruiter), Foued Makhlou, MD, Jean-François Poussel, MD, Yohann Picard, MD, François Braun, MD, Pauline Trognon, MD (top 10 recruiter), François Fourrier, MD, Patrick Goldstein, MD, Marie Girot, MD, Pierre Gosselin, MD, Francesco Santoli, MD, Pierre Charestan, MD (top 10 recruiter), Claire Poly, MD, Hervé Mentec, MD, Catherine Le Gall, MD, Karima Sahraoui, MD; Christophe Baillard, MD, Nicolas Javaud, MD (top 10 recruiter), Benoît Misset, MD, Maité Garrouste-Orgeas MD, Olivier Ganansia, MD (top 10 recruiter), François-Xavier Rooryck, MD, Jean Luc Aim, MD, Abudlrazak El Rifai, MD, Jean Reignier, MD, PhD, Laurent Martin-Lefevre, MD, Philippe Fradin, MD, Claire Mauriat, MD, Emelyne Cwicklinski, MD, Michel Slama, MD, PhD, Hervé Dupont, MD, PhD, Christine Ammirati, MD, Justine Gallou, MD, Muriel Fartoukh, MD, PhD, Michel Djibre, MD, Patrik Ray, MD, PhD (top 10 recruiter), Edwin Rouff, MD, Bertrand Souweine, MD, PhD, Ali Ait Hssain, MD, Jeannot Schmidt, MD, Daniel Pic, MD, Farès Moustafa, MD, Alain Mercat, MD, PhD, Nicolas Lerolle, MD, PhD, Pierre-Marie Roy, MD; Frédéric Baud, MD, PhD, Patrick Plaisance, MD, Sophie Montagnon, MD, Bertrand Galichon, MD (top 10 recruiter), Michel Wolff, MD, Bruno Mourvillier, MD, PhD, Enrique Casalino, MD, Christophe Choquet, MD, Julien Bernard, MD, Gaëlle Juillien, MD, Jean-Yves Fagon, MD, Emmanuel Guerot, MD, Philippe Juvin, MD, Anabela Patzak, MD (top 10 recruiter), Bruno Verdière, MD, Vincent Ioos, MD, Marie-Clément Kouka, MD, Audrey Berthoumieu, MD, Christian Richard, MD, PhD, Raphael Maurice, MD, Sophie Sarnel, MD, Stéphane Diez, MD, Antoine Vieillard Baron, MD, PhD, Sébastien Beaune, MD, Julie Grenet, MD; Unité de Recherche Clinique Paris Île-de-France Ouest: Sylvie Azerad, PharmD; Department of Anesthesiolgy and Critical Care–Laval University: Guillaume Leblanc, MD; Sorbonne Universités–Pierre et Marie Curie: Tabassome Simon, MD, PhD.
Additional Contributions: We thank Philippe Aegerter, MD, PhD, Unité de Recherche Clinique Ouest–APHP, for creation of the database, all of the physicians and nurses from the study sites for their valuable cooperation with the study, and the staff from the Unité de Recherche Clinique and Clinical Research Unit–Paris Est: Laura Wakselman, MSc, Sarah Salhi, MSc (project coordination), Amal Abderrahim, MSc, Vanessa Lemaître, Amina Rasnaama, Gobiga Visagamoorthy, Arnaud Fruchart, MSc, Cécile Straub, PhD, Élodie Bouvier, PhD, Emeline Julita, PhD, Florian D’arco, MSc, Meena Devadasan, MSc, Rabia Moktari, MSc, Samira Aklil, MSc, Sarah Allouche, MSc, Wissem Boucenna, MSc (clinical research assistants–clinical research unit), and Hélène Fromentin, MSc, Judith Leblanc, PhD, and Maria Martin (study nurses–clinical research center). No compensation was provided for these contributions.
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