Bertrand Guidet1,2,3, Guillaume Leblanc1,4, Tabassome Simon2,5, Maguy Woimant6, Jean-Pierre Quenot7,8, Olivier Ganansia9, Maxime Maignan10, Youri Yordanov11, Samuel Delerme12, Benoit Doumenc13, Muriel Fartoukh14, Pierre Charestan15, Pauline Trognon16, Bertrand Galichon17, Nicolas Javaud18, Anabela Patzak19, Maïté Garrouste-Orgeas20, Caroline Thomas21, Sylvie Azerad22, Dominique Pateron2,11, Ariane Boumendil1. 1. Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Service de Réanimation Médicale, Paris, France. 2. Sorbonne Universités, Université Pierre et Marie Curie, Paris, France. 3. Institut National de la Santé et de la Recherche Médicale (INSERM), UMR S 1136, Institut Pierre Louis d'Épidémiologie et de Santé Publique, Paris, France. 4. Department of Anesthesiology and Critical Care, Université Laval, Québec City, Québec, Canada. 5. AP-HP, Hôpital Saint-Antoine, Department of Pharmacology and Unité de Recherche Clinique de l'Est Parisien, Paris, France. 6. AP-HP, Hôpital Avicenne, Service d'Accueil des Urgences (SAU), Bobigny, France. 7. CHU de Dijon, Service de Réanimation Médicale, Dijon, France. 8. Equipe LIPNESS, INSERM UMR 866, Université de Bourgogne Franche Comté, Dijon, France. 9. Hôpital Saint-Joseph, SAU, Paris, France. 10. CHU de Grenoble, SAU, Grenoble, France. 11. AP-HP, Hôpital Saint-Antoine, SAU, Paris, France. 12. AP-HP, Hôpital Pitié Salpêtrière, SAU, Paris, France. 13. AP-HP, Hôpital Cochin, SAU, Paris, France. 14. AP-HP, Hôpital Tenon, Service de Réanimation, Paris, France. 15. Hôpital Robert Ballanger, SAU, Aulnay-Sous-Bois, France. 16. Hôpital Notre-Dame-de-Bon-Secours, SAU, Metz, France. 17. AP-HP, Hôpital Lariboisière, SAU, Paris, France. 18. Hôpital Jean Verdier, SAU, Bondy, France. 19. AP-HP, Hôpital européen Georges-Pompidou, SAU, Paris, France. 20. Hôpital Saint-Joseph, Service de Réanimation, Paris, France. 21. AP-HP, Hôpital Saint-Antoine, Service de Gériatrie Aiguë, Paris, France. 22. AP-HP, Hôpital Ambroise Paré, Unité de Recherche Clinique Paris Île-de-France Ouest, Boulogne-Billancourt, 92104, France.
Abstract
Importance: 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. Objective: 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. Interventions: 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. Results: 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. Trial Registration: clinicaltrials.gov Identifier: NCT01508819.
RCT Entities:
Importance: 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. Objective: 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. Interventions: 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. Results: 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. Trial Registration: clinicaltrials.gov Identifier: NCT01508819.
Authors: Daren Heyland; Deborah Cook; Sean M Bagshaw; Allan Garland; Henry T Stelfox; Sangeeta Mehta; Peter Dodek; Jim Kutsogiannis; Karen Burns; John Muscedere; Alexis F Turgeon; Rob Fowler; Xuran Jiang; Andrew G Day Journal: Crit Care Med Date: 2015-07 Impact factor: 7.598
Authors: B Gandek; J E Ware; N K Aaronson; G Apolone; J B Bjorner; J E Brazier; M Bullinger; S Kaasa; A Leplege; L Prieto; M Sullivan Journal: J Clin Epidemiol Date: 1998-11 Impact factor: 6.437
Authors: H Flaatten; D W de Lange; A Artigas; D Bin; R Moreno; S Christensen; G M Joynt; Sean M Bagshaw; C L Sprung; D Benoit; M Soares; B Guidet Journal: Intensive Care Med Date: 2017-02-25 Impact factor: 17.440
Authors: Lior Fuchs; Victor Novack; Stuart McLennan; Leo Anthony Celi; Yael Baumfeld; Shinhyuk Park; Michael D Howell; Daniel S Talmor Journal: PLoS One Date: 2014-04-03 Impact factor: 3.240
Authors: Christopher E Cox; Maren K Olsen; David Casarett; Krista Haines; Mashael Al-Hegelan; Raquel R Bartz; Jason N Katz; Colleen Naglee; Deepshikha Ashana; Daniel Gilstrap; Jessie Gu; Alice Parish; Allie Frear; Deepthi Krishnamaneni; Andrew Corcoran; Sharron L Docherty Journal: Contemp Clin Trials Date: 2020-09-29 Impact factor: 2.226
Authors: Bertrand Guidet; Hans Flaatten; Ariane Boumendil; Alessandro Morandi; Finn H Andersen; Antonio Artigas; Guido Bertolini; Maurizio Cecconi; Steffen Christensen; Loredana Faraldi; Jesper Fjølner; Christian Jung; Brian Marsh; Rui Moreno; Sandra Oeyen; Christina Agwald Öhman; Bernardo Bollen Pinto; Ivo W Soliman; Wojciech Szczeklik; Andreas Valentin; Ximena Watson; Tilemachos Zafeiridis; Dylan W De Lange Journal: Intensive Care Med Date: 2018-05-17 Impact factor: 17.440
Authors: Thomas S Valley; Andrew J Admon; Darin B Zahuranec; Allan Garland; Angela Fagerlin; Theodore J Iwashyna Journal: Crit Care Med Date: 2019-01 Impact factor: 7.598