title: Neurologic Function and Health-Related Quality of Life in Patients Following Targeted Temperature Management at 33°C vs 36°C After Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial.
abstract: OBJECTIVE
  Brain injury affects neurologic function and quality of life in survivors after cardiac arrest.
  
  
  OBJECTIVE
  To compare the effects of 2 target temperature regimens on long-term cognitive function and quality of life after cardiac arrest.
  
  
  METHODS
  In this multicenter, international, parallel group, assessor-masked randomized clinical trial performed from November 11, 2010, through January 10, 2013, we enrolled 950 unconscious adults with cardiac arrest of presumed cardiac cause from 36 intensive care units in Europe and Australia. Eleven patients were excluded from analysis for a total sample size of 939.
  
  
  METHODS
  Targeted temperature management at 33°C vs 36°C.
  
  
  METHODS
  Cognitive function was measured by the Mini-Mental State Examination (MMSE) and assessed by observers through the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). Patients reported their activities in daily life and mental recovery through Two Simple Questions and their quality of life through the Medical Outcomes Study 36-Item Short Form Health Survey, version 2.
  
  
  RESULTS
  In the modified intent-to-treat population, including nonsurvivors, the median MMSE score was 14 in the 33°C group (interquartile range [IQR], 0-28) vs 17 in the 36°C group (IQR, 0-29) (P = .77), and the IQCODE score was 115 (IQR, 79-130) vs 115 (IQR, 80-130) (P = .57) in the 33°C and 36°C groups, respectively. The median MMSE score for survivors was within the reference range and similar (33°C group median, 28; IQR, 26-30; vs 36°C group median, 28; IQR, 25-30; P = .61). The median IQCODE score was within the minor deficit range (33°C group median, 79.5; IQR, 78.0-85.9; vs 36°C group median, 80.7; IQR, 78.0-86.9; P = .04). A total of 18.8% vs 17.5% of survivors reported needing help with everyday activities (P = .71), and 66.5% in the 33°C group vs 61.8% in the 36°C group reported that they thought they had made a complete mental recovery (P = .32). The mean (SD) mental component summary score was 49.1 (12.5) vs 49.0 (12.2) (P = .79), and the mean (SD) physical component summary score was 46.8 (13.8) and 47.5 (13.8) (P = .45), comparable to the population norm.
  
  
  CONCLUSIONS
  Quality of life was good and similar in patients with cardiac arrest receiving targeted temperature management at 33°C or 36°C. Cognitive function was similar in both intervention groups, but many patients and observers reported impairment not detected previously by standard outcome scales.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01020916.
authors.affiliation: Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund, Sweden2Department of Clinical Sciences, Lund University, Lund, Sweden.
authors.forename: Tobias
authors.initials: T
authors.lastname: Cronberg
authors.affiliation: Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund, Sweden2Department of Clinical Sciences, Lund University, Lund, Sweden.
authors.forename: Gisela
authors.initials: G
authors.lastname: Lilja
authors.affiliation: Department of Intensive Care, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Janneke
authors.initials: J
authors.lastname: Horn
authors.affiliation: Department of Cardiology, The Heart Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
authors.forename: Jesper
authors.initials: J
authors.lastname: Kjaergaard
authors.affiliation: Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom.
authors.forename: Matt P
authors.initials: MP
authors.lastname: Wise
authors.affiliation: Intensive Care Unit, Santa Maria degli Angeli, Pordenone, Italy.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Pellis
authors.affiliation: Department of Anesthesiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
authors.forename: Jan
authors.initials: J
authors.lastname: Hovdenes
authors.affiliation: Department of Anesthesiology, Pharmacology and Intensive Care, Geneva University Hospital, Geneva, Switzerland.
authors.forename: Yvan
authors.initials: Y
authors.lastname: Gasche
authors.affiliation: Department of Intensive Care, Liverpool Hospital, Sydney, New South Wales, Australia.
authors.forename: Anders
authors.initials: A
authors.lastname: Åneman
authors.affiliation: Department of Anesthesiology and Intensive Care, Centre Hospitalier de Luxembourg, Luxembourg.
authors.forename: Pascal
authors.initials: P
authors.lastname: Stammet
authors.affiliation: Department of Clinical Sciences, Lund University, Lund, Sweden11Department of Cardiology, Lund University, Lund, Sweden.
authors.forename: David
authors.initials: D
authors.lastname: Erlinge
authors.affiliation: Department of Clinical Sciences, Lund University, Lund, Sweden12Department of Intensive and Perioperative Care, Skåne University Hospital, Lund, Sweden.
authors.forename: Hans
authors.initials: H
authors.lastname: Friberg
authors.affiliation: Department of Cardiology, The Heart Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Hassager
authors.affiliation: Department of Intensive Care, Academic Medical Center, Amsterdam, the Netherlands13Department of Intensive Care, Medical Center Leeuwarden, Leeuwarden, the Netherlands.
authors.forename: Michael
authors.initials: M
authors.lastname: Kuiper
authors.affiliation: Department of Cardiothoracic Anesthesiology, The Heart Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
authors.forename: Michael
authors.initials: M
authors.lastname: Wanscher
authors.affiliation: Department of Intensive Care, Rijnstaate Hospital, Arnhem, the Netherlands.
authors.forename: Frank
authors.initials: F
authors.lastname: Bosch
authors.affiliation: Department of Intensive Care, Royal Bournemouth Hospital, Bournemouth, United Kingdom.
authors.forename: Julius
authors.initials: J
authors.lastname: Cranshaw
authors.affiliation: Department of Intensive Care, Kantonsspital, St Gallen, Switzerland.
authors.forename: Gian-Reto
authors.initials: GR
authors.lastname: Kleger
authors.affiliation: Departement of Anesthesia and Intensive Care, Örebro University Hospital, Örebro, Sweden.
authors.forename: Stefan
authors.initials: S
authors.lastname: Persson
authors.affiliation: Department of Intensive and Perioperative Care, Skåne University Hospital, Malmö, Sweden.
authors.forename: Johan
authors.initials: J
authors.lastname: Undén
authors.affiliation: Department of Intensive Care, Royal Berkshire Hospital, Reading, United Kingdom.
authors.forename: Andrew
authors.initials: A
authors.lastname: Walden
authors.affiliation: Copenhagen Trial Unit, Centre of Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Winkel
authors.affiliation: Copenhagen Trial Unit, Centre of Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
authors.forename: Jørn
authors.initials: J
authors.lastname: Wetterslev
authors.affiliation: Department of Clinical Sciences, Lund University, Lund, Sweden22Department of Anesthesiology and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden.
authors.forename: Niklas
authors.initials: N
authors.lastname: Nielsen
mesh_terms: D000368:Aged; D001831:Body Temperature / Q000502:physiology*; D003072:Cognition Disorders / Q000209:etiology*; D005260:Female; D006801:Humans; D007036:Hypothermia, Induced; D008297:Male; D008875:Middle Aged; D058687:Out-of-Hospital Cardiac Arrest / Q000150:complications / Q000628:therapy*; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D016037:Single-Blind Method