Cognitive Impairment Following Cardiac Arrest and Target Temperature Management
NCT ID: NCT01946932
Last Updated: 2013-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
287 participants
INTERVENTIONAL
2011-06-30
2013-11-30
Brief Summary
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The primary aim of this sub-study is to compare the amount of cognitive impairment in cardiac arrest survivors treated with 33 degrees and 36 degrees and with a matched group of control patients with myocardial infarction.
Our secondary aims are:
* To investigate the impact of cognitive impairment on our patients' ability to participate in society and their health related quality of life.
* To investigate the relationship between our patients cognitive impairments and their relatives/informants health related quality of life and feelings of burden.
* To test the hypothesis that the simple cognitive screening battery used in the TTM main trial is sensitive enough to detect all patients with significant cognitive disability.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Cardiac Arrest 33°
survivors with temperature treatment 33°
Temperature treatment
Cardiac Arrest survivors 36°
survivors with temperature treatment 36°
Temperature treatment
Interventions
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Temperature treatment
Eligibility Criteria
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Inclusion Criteria
* Out-of-Hospital Cardiac Arrest (OHCA)of presumed cardiac cause
* Unconsciousness after sustained return of spontaneous circulation (ROSC)
Exclusion Criteria
* Suspected or confirmed acute intracranial bleeding
* Suspected or confirmed stroke
* Unwitnessed asystole
* Known limitations in therapy and Do Not Resuscitate-order
* Known disease making 180 days survival unlikely
* Known prearrest status Cerebral Performance Category (CPC)3 or 4
* Temperature \<30°on admission
* 4 hours (240 minutes) from ROSC to screening
* Systolic blood pressure \<80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump
* In-hospital cardiac arrest
* OHCA of presumed non-cardiac arrest cause
* Disability to speak the site language well enough to complete tests without interpreter
* Controls should never have suffered a cardiac arrest
18 Years
ALL
No
Sponsors
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Lund University
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Copenhagen University Hospital, Denmark
OTHER
Azienda Ospedaliera Santa Maria Degli Angeli
OTHER
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
University Hospital of Wales
OTHER
Region Skane
OTHER
Responsible Party
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Principal Investigators
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Tobias Cronberg, MD, PhD
Role: STUDY_CHAIR
Department of Clinical Sciences, Lund University, Lund, Sweden and Department of Neurology, Skåne University Hospital, Lund, Sweden
Niklas Nielsen, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Sciences, Lund University, Lund Sweden and Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden
Jesper Kjaergaard, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Heart Centrem Copenhagen University, Copenhagen, Denmark
Janneke Horn, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Intensive Care, Academic Medical Centrum, Amsterdam, Netherlands
Tommaso Pellis, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Intensive Care Unit Santa Maria Degli Angeli, Pordenonde, Italy
Matthew P Wise, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Adult Critical Care, University Hospital of Wales, Cardiff, Untied Kingdom
Gisela Lilja, OT
Role: STUDY_DIRECTOR
Lund University Hospital, Lund, Sweden
Locations
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Rigshospitalet
Copenhagen, , Denmark
San Martino Hospital
Genova, , Italy
Santa Maria degli Angeli Hospital
Pordenone, , Italy
Ospedale Universitario di Cattinaria
Trieste, , Italy
Academisch Medisch Centrum (AMC)
Amsterdam, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Rijnstate Hospital
Arnhem, , Netherlands
Leeuwarden Hospital
Leeuwarden, , Netherlands
Sahlgrenska University Hospital, Thorax
Gothenburg, , Sweden
Sahlgrenska University Hospital, Östra
Gothenburg, , Sweden
Sahlgrenska University Hospital
Gothenburg, , Sweden
Helsingborg Hospital
Helsingborg, , Sweden
Karlstad Central Hospital
Karlstad, , Sweden
Skåne University Hospital, Lund
Lund, , Sweden
Skåne University Hospital, Malmö
Malmo, , Sweden
Örebro University Hospital
Örebro, , Sweden
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
St Georges' Hospital
London, , United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, , United Kingdom
Countries
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References
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Cronberg T, Lilja G, Rundgren M, Friberg H, Widner H. Long-term neurological outcome after cardiac arrest and therapeutic hypothermia. Resuscitation. 2009 Oct;80(10):1119-23. doi: 10.1016/j.resuscitation.2009.06.021. Epub 2009 Jul 23.
Nielsen N, Wetterslev J, al-Subaie N, Andersson B, Bro-Jeppesen J, Bishop G, Brunetti I, Cranshaw J, Cronberg T, Edqvist K, Erlinge D, Gasche Y, Glover G, Hassager C, Horn J, Hovdenes J, Johnsson J, Kjaergaard J, Kuiper M, Langorgen J, Macken L, Martinell L, Martner P, Pellis T, Pelosi P, Petersen P, Persson S, Rundgren M, Saxena M, Svensson R, Stammet P, Thoren A, Unden J, Walden A, Wallskog J, Wanscher M, Wise MP, Wyon N, Aneman A, Friberg H. Target Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design. Am Heart J. 2012 Apr;163(4):541-8. doi: 10.1016/j.ahj.2012.01.013.
Heimburg K, Cronberg T, Tornberg AB, Ullen S, Friberg H, Nielsen N, Hassager C, Horn J, Kjaergaard J, Kuiper M, Rylander C, Wise MP, Lilja G. Self-reported limitations in physical function are common 6 months after out-of-hospital cardiac arrest. Resusc Plus. 2022 Jul 19;11:100275. doi: 10.1016/j.resplu.2022.100275. eCollection 2022 Sep.
Lilja G, Nielsen N, Bro-Jeppesen J, Dunford H, Friberg H, Hofgren C, Horn J, Insorsi A, Kjaergaard J, Nilsson F, Pelosi P, Winters T, Wise MP, Cronberg T. Return to Work and Participation in Society After Out-of-Hospital Cardiac Arrest. Circ Cardiovasc Qual Outcomes. 2018 Jan;11(1):e003566. doi: 10.1161/CIRCOUTCOMES.117.003566.
Lilja G, Nilsson G, Nielsen N, Friberg H, Hassager C, Koopmans M, Kuiper M, Martini A, Mellinghoff J, Pelosi P, Wanscher M, Wise MP, Ostman I, Cronberg T. Anxiety and depression among out-of-hospital cardiac arrest survivors. Resuscitation. 2015 Dec;97:68-75. doi: 10.1016/j.resuscitation.2015.09.389. Epub 2015 Oct 9.
Lilja G, Nielsen N, Friberg H, Horn J, Kjaergaard J, Nilsson F, Pellis T, Wetterslev J, Wise MP, Bosch F, Bro-Jeppesen J, Brunetti I, Buratti AF, Hassager C, Hofgren C, Insorsi A, Kuiper M, Martini A, Palmer N, Rundgren M, Rylander C, van der Veen A, Wanscher M, Watkins H, Cronberg T. Cognitive function in survivors of out-of-hospital cardiac arrest after target temperature management at 33 degrees C versus 36 degrees C. Circulation. 2015 Apr 14;131(15):1340-9. doi: 10.1161/CIRCULATIONAHA.114.014414. Epub 2015 Feb 13.
Lilja G, Nielsen N, Friberg H, Horn J, Kjaergaard J, Pellis T, Rundgren M, Wetterslev J, Wise MP, Nilsson F, Cronberg T. Cognitive function after cardiac arrest and temperature management; rationale and description of a sub-study in the Target Temperature Management trial. BMC Cardiovasc Disord. 2013 Oct 12;13:85. doi: 10.1186/1471-2261-13-85.
Other Identifiers
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TTMcogsub
Identifier Type: -
Identifier Source: org_study_id