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Effects of Hypothermia vs Normothermia on Societal Participation and Cognitive Function at 6 Months in Survivors After Out-of-Hospital Cardiac Arrest: A Predefined Analysis of the TTM2 Randomized Clinical Trial.
Lilja, Gisela; Ullén, Susann; Dankiewicz, Josef; Friberg, Hans; Levin, Helena; Nordström, Erik Blennow; Heimburg, Katarina; Jakobsen, Janus Christian; Ahlqvist, Marita; Bass, Frances; Belohlavek, Jan; Olsen, Roy Bjørkholt; Cariou, Alain; Eastwood, Glenn; Fanebust, Hans Rune; Grejs, Anders M; Grimmer, Lisa; Hammond, Naomi E; Hovdenes, Jan; Hrecko, Juraj; Iten, Manuela; Johansen, Henriette; Keeble, Thomas R; Kirkegaard, Hans; Lascarrou, Jean-Baptiste; Leithner, Christoph; Lesona, Mildred Eden; Levis, Anja; Mion, Marco; Moseby-Knappe, Marion; Navarra, Leanlove; Nordberg, Per; Pelosi, Paolo; Quayle, Rachael; Rylander, Christian; Sandberg, Helena; Saxena, Manoj; Schrag, Claudia; Siranec, Michal; Tiziano, Cassina; Vignon, Philippe; Wendel-Garcia, Pedro David; Wise, Matt P; Wright, Kim; Nielsen, Niklas; Cronberg, Tobias.
Afiliación
  • Lilja G; Clinical Studies Sweden, Forum South, Skane University Hospital, Lund, Sweden.
  • Ullén S; Clinical Studies Sweden, Forum South, Skane University Hospital, Lund, Sweden.
  • Dankiewicz J; Cardiology, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden.
  • Friberg H; Anesthesia and Intensive Care, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Malmö, Sweden.
  • Levin H; Anesthesia and Intensive Care, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Malmö, Sweden.
  • Nordström EB; Neurology, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden.
  • Heimburg K; Neurology, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden.
  • Jakobsen JC; Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark.
  • Ahlqvist M; Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Denmark.
  • Bass F; Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.
  • Belohlavek J; Critical Care Program, The George Institute for Global Health and UNSW Sydney, Sydney, New South Wales, Australia.
  • Olsen RB; Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital, Sydney, New South Wales, Australia.
  • Cariou A; 2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Czech Republic.
  • Eastwood G; Department of Anesthesiology, Sørlandet Hospital, Arendal, Norway.
  • Fanebust HR; Cochin University Hospital (APHP) and Paris Cité University (medical school), Paris, France.
  • Grejs AM; Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia.
  • Grimmer L; Cardiac Intensive Care Unit, Haukeland University Hospital, Bergen, Norway.
  • Hammond NE; Department of Intensive Care Medicine and Department of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark.
  • Hovdenes J; University Hospitals Bristol and Weston NHS Trust, Bristol, United Kingdom.
  • Hrecko J; Critical Care Program, The George Institute for Global Health and UNSW Sydney, Sydney, New South Wales, Australia.
  • Iten M; Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital, Sydney, New South Wales, Australia.
  • Johansen H; Department of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
  • Keeble TR; The 1st Department of Internal Medicine, Cardioangiology, Medical Faculty of Charles University in Hradec Králové and University Hospital Hradec Králové, Hradec Králové, Czech Republic.
  • Kirkegaard H; Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Lascarrou JB; Department of Neurology, Rikshospitalet, Oslo University Hospital, Oslo, Norway.
  • Leithner C; Essex Cardio Thoracic Centre, Basildon, Essex, UK Thurrock University Hospitals, Basildon, United Kingdom.
  • Lesona ME; MTRC, Anglia Ruskin University Faculty of Health Education Medicine & Social Care, Chelmsford, Essex, United Kingdom.
  • Levis A; Research Center for Emergency Medicine, Emergency Department Aarhus University Hospital and Department of Clinical Medicine Aarhus University, Aarhus, Denmark.
  • Mion M; Medecine Intensive Reanimation, CHU Nantes, Nantes, France.
  • Moseby-Knappe M; Charité- Universitätsmedizin Berlin, coroporate member of Freie Universität Berlin and Humboldt- Universität-zu-Berlin, Department of Neurology, Berlin, Germany.
  • Navarra L; Intensive Care Unit, Wellington hospital, Wellington, New Zealand.
  • Nordberg P; Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Pelosi P; Department of Anesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Quayle R; Essex Cardio Thoracic Centre, Basildon, Essex, UK Thurrock University Hospitals, Basildon, United Kingdom.
  • Rylander C; MTRC, Anglia Ruskin University Faculty of Health Education Medicine & Social Care, Chelmsford, Essex, United Kingdom.
  • Sandberg H; Neurology, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden.
  • Saxena M; Medical Research Institute of New Zealand, Wellington, New Zealand.
  • Schrag C; Center for Resuscitation Sciences, Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
  • Siranec M; Function Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.
  • Tiziano C; Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.
  • Vignon P; Anesthesia and Critical Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy.
  • Wendel-Garcia PD; Manchester Foundation Trust, Manchester, United Kingdom.
  • Wise MP; The Greater Manchester NIHR Clinical Research Network, Manchester, United Kingdom.
  • Wright K; Department of Surgical Sciences, Anaesthesiology and Intensive Care Medicine, Uppsala University, Sweden.
  • Nielsen N; Hallands hospital, Halmstad, Sweden.
  • Cronberg T; St George Hospital Clinical School, The George institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
JAMA Neurol ; 80(10): 1070-1079, 2023 Oct 01.
Article en En | MEDLINE | ID: mdl-37548968
Importance: The Targeted Hypothermia vs Targeted Normothermia After Out-of-Hospital Cardiac Arrest (TTM2) trial reported no difference in mortality or poor functional outcome at 6 months after out-of-hospital cardiac arrest (OHCA). This predefined exploratory analysis provides more detailed estimation of brain dysfunction for the comparison of the 2 intervention regimens. Objectives: To investigate the effects of targeted hypothermia vs targeted normothermia on functional outcome with focus on societal participation and cognitive function in survivors 6 months after OHCA. Design, Setting, and Participants: This study is a predefined analysis of an international multicenter, randomized clinical trial that took place from November 2017 to January 2020 and included participants at 61 hospitals in 14 countries. A structured follow-up for survivors performed at 6 months was by masked outcome assessors. The last follow-up took place in October 2020. Participants included 1861 adult (older than 18 years) patients with OHCA who were comatose at hospital admission. At 6 months, 939 of 1861 were alive and invited to a follow-up, of which 103 of 939 declined or were missing. Interventions: Randomization 1:1 to temperature control with targeted hypothermia at 33 °C or targeted normothermia and early treatment of fever (37.8 °C or higher). Main outcomes and measures: Functional outcome focusing on societal participation assessed by the Glasgow Outcome Scale Extended ([GOSE] 1 to 8) and cognitive function assessed by the Montreal Cognitive Assessment ([MoCA] 0 to 30) and the Symbol Digit Modalities Test ([SDMT] z scores). Higher scores represent better outcomes. Results: At 6 months, 836 of 939 survivors with a mean age of 60 (SD, 13) (range, 18 to 88) years (700 of 836 male [84%]) participated in the follow-up. There were no differences between the 2 intervention groups in functional outcome focusing on societal participation (GOSE score, odds ratio, 0.91; 95% CI, 0.71-1.17; P = .46) or in cognitive function by MoCA (mean difference, 0.36; 95% CI,-0.33 to 1.05; P = .37) and SDMT (mean difference, 0.06; 95% CI,-0.16 to 0.27; P = .62). Limitations in societal participation (GOSE score less than 7) were common regardless of intervention (hypothermia, 178 of 415 [43%]; normothermia, 168 of 419 [40%]). Cognitive impairment was identified in 353 of 599 survivors (59%). Conclusions: In this predefined analysis of comatose patients after OHCA, hypothermia did not lead to better functional outcome assessed with a focus on societal participation and cognitive function than management with normothermia. At 6 months, many survivors had not regained their pre-arrest activities and roles, and mild cognitive dysfunction was common. Trial Registration: ClinicalTrials.gov Identifier: NCT02908308.

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Prognostic_studies Idioma: En Revista: JAMA Neurol Año: 2023 Tipo del documento: Article País de afiliación: Suecia Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Prognostic_studies Idioma: En Revista: JAMA Neurol Año: 2023 Tipo del documento: Article País de afiliación: Suecia Pais de publicación: Estados Unidos