Target temperature management after out-of-hospital cardiac arrest - A randomized, parallel-group, assessor-blinded clinical trial - Rationale and design

American Heart Journal

Volumn 163, Issue 4, 2012, Pages 541-548

  Nielsen, Niklas ^a   Wetterslev, Jørn ^b   Al Subaie, Nawaf ^c   Andersson, Bertil ^d   Bro Jeppesen, John ^b   Bishop, Gillian ^e   Brunetti, Iole ^f   Cranshaw, Julius ^g   Cronberg, Tobias ^h   Edqvist, Kristin ⁱ   Erlinge, David ^h   Gasche, Yvan ^j   Glover, Guy ^k   Hassager, Christian ^y   Horn, Janneke ^l   Hovdenes, Jan ^m   Johnsson, Jesper ^h   Kjaergaard, Jesper ^y   Kuiper, Michael ⁿ   Langørgen, Jørund ^o   MacKen, Lewis ^p   Martinell, Louise ^x   Martner, Patrik ^x   Pellis, Thomas ^q   Pelosi, Paolo ^f   Petersen, Per ^q   Persson, Stefan ^r   Rundgren, Malin ^h   Saxena, Manoj ^s   Svensson, Robert ^t   Stammet, Pascal ^u   Thorén, Anders ^x   Undén, Johan ^h   Walden, Andrew ^v   Wallskog, Jesper ^w   Wanscher, Michael ^y   Wise, Matthew P ^x   Wyon, Nicholas ^y   Åneman, Anders ^z   Friberg, Hans ^h   more..

^a HELSINGBORG HOSPITAL   (Sweden)

^b Mental Health Services CPH   (Denmark)

^c ST GEORGE S HOSPITAL   (United Kingdom)

^d SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^e Department of Intensive Care   (Australia)

^f UNIVERSITY OF GENOA   (Italy)

^g ROYAL BOURNEMOUTH HOSPITAL   (United Kingdom)

^h LUND UNIVERSITY HOSPITAL   (Sweden)

ⁱ CENTRAL HOSPITAL   (Sweden)

^j GENEVA UNIVERSITY HOSPITALS   (Switzerland)

^k GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

^l ACADEMIC MEDICAL CENTER   (Netherlands)

^m OSLO UNIVERSITY HOSPITAL   (Norway)

ⁿ Intensive Care Unit   (Netherlands)

^o HAUKELAND UNIVERSITY HOSPITAL   (Norway)

^p ROYAL NORTH SHORE HOSPITAL   (Australia)

^q Santa Maria Degli Angeli ^*  (Sweden)

^r ÖREBRO UNIVERSITY HOSPITAL   (Sweden)

^s ST GEORGE HOSPITAL   (Australia)

^t VRINNEVI HOSPITAL   (Sweden)

^u CENTRE HOSPITALIER DE LUXEMBOURG   (Luxembourg)

^v ROYAL BERKSHIRE HOSPITAL   (United Kingdom)

^w Kungalv Hospital   (Sweden)

^x UNIVERSITY HOSPITAL OF WALES   (United Kingdom)

^y LINKÖPING UNIVERSITY HOSPITAL   (Sweden)

^z LIVERPOOL HOSPITAL   (Australia)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COGNITION; FOLLOW UP; HOSPITAL DISCHARGE; HUMAN; INDUCED HYPOTHERMIA; MORTALITY; MULTICENTER STUDY (TOPIC); OUT OF HOSPITAL CARDIAC ARREST; PARALLEL DESIGN; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETURN OF SPONTANEOUS CIRCULATION; RISK ASSESSMENT; TARGET TEMPERATURE MANAGEMENT;

BODY TEMPERATURE; HUMANS; MULTICENTER STUDIES AS TOPIC; OUT-OF-HOSPITAL CARDIAC ARREST; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 84860199176     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2012.01.013     Document Type: Article

References (28)

1. R. Busto, W.D. Dietrich, and M.Y. Globus Small differences in intraischemic brain temperature critically determine the extent of ischemic neuronal injury J Cereb Blood Flow Metab 7 1987 729 738
2. F. Sterz, P. Safar, and S. Tisherman Mild hypothermic cardiopulmonary resuscitation improves outcome after prolonged cardiac arrest in dogs Crit Care Med 19 1991 379 389
3. HACA-Study-Group Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest N Engl J Med 346 2002 549 556
4. S.A. Bernard, T.W. Gray, and M.D. Buist Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia N Engl J Med 346 2002 557 563
5. M.A. Peberdy, C.W. Callaway, and R.W. Neumar Part 9: post-cardiac arrest care: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Circulation 122 18 Suppl 3 2010 S768 S786
6. J.H. Walters, P.T. Morley, and J.P. Nolan The role of hypothermia in post-cardiac arrest patients with return of spontaneous circulation: a systematic review Resuscitation 82 2011 508 516
7. N. Nielsen, H. Friberg, and C. Gluud Hypothermia after cardiac arrest should be further evaluated-A systematic review of randomised trials with meta-analysis and trial sequential analysis Int J Cardiol 151 2011 333 341
8. N. Nielsen, J. Hovdenes, and F. Nilsson Outcome, timing and adverse events in therapeutic hypothermia after out-of-hospital cardiac arrest Acta Anaesthesiol Scand 53 2009 926 934
9. ICH Harmonised Tripartite Guideline Statistical principles for clinical trials. International Conference on Harmonisation E9 Expert Working Group Stat Med 18 1999 1905 1942
10. D. Moher, K.F. Schulz, and D. Altman The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials JAMA 285 2001 1987 1991
11. B. Jennett, and M. Bond Assessment of outcome after severe brain damage Lancet 1 1975 480 484
12. J. Rankin. Cerebral vascular accidents in patients over the age of 60. II. Prognosis Scott Med J 2 1957 200 215
13. M.F. Folstein, S.E. Folstein, and P.R. McHugh "Mini-mental state." A practical method for grading the cognitive state of patients for the clinician J Psychiatr Res 12 1975 189 198
14. A.F. Jorm A short form of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): development and cross-validation Psychol Med 24 1994 145 153
15. J.E. Ware Jr., and C.D. Sherbourne The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection Med Care 30 1992 473 483
16. W.T. Longstreth Jr., G. Nichol, and L. Van Ottingham Two simple questions to assess neurologic outcomes at 3 months after out-of-hospital cardiac arrest: experience from the public access defibrillation trial Resuscitation 81 2010 530 533
17. J.P. Ioannidis, S.J. Evans, and P.C. Gotzsche Better reporting of harms in randomized trials: an extension of the CONSORT statement Ann Intern Med 141 2004 781 788
18. J. Wetterslev, K. Thorlund, and J. Brok Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis J Clin Epidemiol 61 2008 64 75
19. J.L. Haybittle Repeated assessment of results in clinical trials of cancer treatment Br J Radiol 44 1971 793 797
20. K.K.G. Lan, and D.L. DeMets Discrete sequential boundaries for clinical trials Biometrika 70 1983 659 663
21. A. Zeiner, M. Holzer, and F. Sterz Hyperthermia after cardiac arrest is associated with an unfavorable neurologic outcome Arch Intern Med 161 2001 2007 2012
22. D. Atkins, D. Best, and P.A. Briss Grading quality of evidence and strength of recommendations BMJ 328 2004 1490
23. M. Holzer, S.A. Bernard, and S. Hachimi-Idrissi Hypothermia for neuroprotection after cardiac arrest: systematic review and individual patient data meta-analysis Crit Care Med 33 2005 414 418
24. N. Nielsen, K. Sunde, and J. Hovdenes Adverse events and their relation to mortality in out-of-hospital cardiac arrest patients treated with therapeutic hypothermia Crit Care Med 39 2011 57 64
25. K. Sunde, M. Pytte, and D. Jacobsen Implementation of a standardised treatment protocol for post resuscitation care after out-of-hospital cardiac arrest Resuscitation 73 2007 29 39
26. J. Arrich, A. Zeiner, and F. Sterz Factors associated with a change in functional outcome between one month and six months after cardiac arrest: a retrospective cohort study Resuscitation 80 2009 876 880
27. J.L. Moran, and P.J. Solomon Therapeutic hypothermia after cardiac arrest-once again Crit Care Resusc 8 2006 151 154
28. A. Langhelle, J. Nolan, and J. Herlitz Recommended guidelines for reviewing, reporting, and conducting research on post-resuscitation care: the Utstein style Resuscitation 66 2005 271 283