Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

NCT01946932 | Completed DMC

• 1 other identifier: TTMcogsub
• Study Type: interventional
• Target: 287
• Locations: 5 countries
• Sites: 20

Brief Summary

This is a steering group approved substudy to the Target Temperature Management trial (TTM, ClinicalTrials.gov Identifier: NCT01020916). TTM compares the effect of two strictly controlled temperature regimes for survivors of out-of-hospital cardiac arrest. 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.

Conditions

Heart Arrest; Out-of-hospital Cardiac Arrest; Cognition Disorders; Brain Injury

Keywords

Induced hypothermia; Mild induced hypothermia; Resuscitation; Therapeutic hypothermia; Neurological function; Cardiovascular diseases; Rehabilitation; Quality of life; Cognition

Outcome Measures

Primary Outcomes (3)

• Rivermead Behavioural Memory Test (RBMT)

  Memory test

  180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI)

• Frontal Assessment Battery (FAB)

  Screening of Executive functions

  180 days after CA or MI

• Symbol Digit Modalities Test (SDMT)

  Assess attention, mental speed and concentration

  180 days after CA or MI

Secondary Outcomes (9)

• Mayo-Portland Adaptability Inventory-4 (MPAI-4)

  180 days after CA or MI

• Short-Form Questionnaire 36 version 2 (SF-36v2)

  180 days after CA or MI

• Zarit Burden Interview

  180 days after CA or MI

• Hospital Anxiety and Depression rating Scale (HADS)

  180 days after CA or MI

• Two Simple Questions (TSQ)

  180 days after CA or MI

Study Arms (2)

Cardiac Arrest 33°

ACTIVE COMPARATOR

survivors with temperature treatment 33°

Other: Temperature treatment

Cardiac Arrest survivors 36°

ACTIVE COMPARATOR

survivors with temperature treatment 36°

Other: Temperature treatment

Interventions

Temperature treatment OTHER

Cardiac Arrest 33°; Cardiac Arrest survivors 36°

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Out-of-Hospital Cardiac Arrest (OHCA)of presumed cardiac cause
• Unconsciousness after sustained return of spontaneous circulation (ROSC)

You may not qualify if:

• Known bleeding diathesis
• 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
• 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

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Copenhagen University Hospital, Denmark: collaborator
• Azienda Ospedaliera Santa Maria Degli Angeli: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• University Hospital of Wales: collaborator

Study Sites (20)

Rigshospitalet

Copenhagen, Denmark

Location

San Martino Hospital

Genova, Italy

Location

Santa Maria degli Angeli Hospital

Pordenone, Italy

Location

Ospedale Universitario di Cattinaria

Trieste, Italy

Location

Academisch Medisch Centrum (AMC)

Amsterdam, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

Leeuwarden Hospital

Leeuwarden, Netherlands

Location

Sahlgrenska University Hospital, Thorax

Gothenburg, Sweden

Location

Sahlgrenska University Hospital, Östra

Gothenburg, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Helsingborg Hospital

Helsingborg, Sweden

Location

Karlstad Central Hospital

Karlstad, Sweden

Location

Skåne University Hospital, Lund

Lund, Sweden

Location

Skåne University Hospital, Malmö

Malmo, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Location

University Hospital of Wales

Cardiff, United Kingdom

Location

St Georges' Hospital

London, United Kingdom

Location

Royal Berkshire NHS Foundation Trust

Reading, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 19631442 BACKGROUND

• 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.

  PMID: 22520518 BACKGROUND

• 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.

  PMID: 36164471 DERIVED

• 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.

  PMID: 29326145 DERIVED

• 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.

  PMID: 26433116 DERIVED

• 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.

  PMID: 25681466 DERIVED

• 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.

  PMID: 24118853 DERIVED

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest; Cognition Disorders; Brain Injuries; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Tobias Cronberg, MD, PhD

  Department of Clinical Sciences, Lund University, Lund, Sweden and Department of Neurology, Skåne University Hospital, Lund, Sweden

  STUDY CHAIR

• Niklas Nielsen, MD,PhD

  Department of Clinical Sciences, Lund University, Lund Sweden and Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden

  PRINCIPAL INVESTIGATOR

• Jesper Kjaergaard, MD, PhD

  The Heart Centrem Copenhagen University, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Janneke Horn, MD, PhD

  Department of Intensive Care, Academic Medical Centrum, Amsterdam, Netherlands

  PRINCIPAL INVESTIGATOR

• Tommaso Pellis, MD, PhD

  Intensive Care Unit Santa Maria Degli Angeli, Pordenonde, Italy

  PRINCIPAL INVESTIGATOR

• Matthew P Wise, MD, PhD

  Adult Critical Care, University Hospital of Wales, Cardiff, Untied Kingdom

  PRINCIPAL INVESTIGATOR

• Gisela Lilja, OT

  Lund University Hospital, Lund, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 20, 2013
• Study Start: June 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 5, 2013

Record last verified: 2013-08

Locations

GB (4); SE (8); DK (1); IT (3); NL (4)