Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

Conditions

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

Keywords

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

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.

Katarina Heimburg, Tobias Cronberg, Åsa Tornberg, Susann Ullén, Hans Friberg et al. (13 authors)

Resuscitation Plus2022-07-199 citations

10.1016/j.resplu.2022.100275

Return to Work and Participation in Society After Out-of-Hospital Cardiac Arrest

Gisela Lilja, Niklas Nielsen, John Bro‐Jeppesen, Hannah Dunford, Hans Friberg et al. (14 authors)

Circulation Cardiovascular Quality and Outcomes2018-01-01162 citations

10.1161/circoutcomes.117.003566

Anxiety and depression among out-of-hospital cardiac arrest survivors.

Lilja G, Nilsson G, Nielsen N, Friberg H, Hassager C, Koopmans M, Kuiper M, Martini A, Mellinghoff J, Pelosi P, Wanscher M, Wise MP, Östman I, Cronberg T.

2015-10-0965 citations

10.1016/j.resuscitation.2015.09.389

Cognitive Function in Survivors of Out-of-Hospital Cardiac Arrest After Target Temperature Management at 33°C Versus 36°C

Gisela Lilja, Niklas Nielsen, Hans Friberg, Janneke Horn, Jesper Kjærgaard et al. (25 authors)

Circulation2015-02-14176 citations

10.1161/circulationaha.114.014414

Cognitive function after cardiac arrest and temperature management; rationale and description of a sub-study in the Target Temperature Management trial.

Lilja G, Nielsen N, Friberg H, Horn J, Kjaergaard J, Pellis T, Rundgren M, Wetterslev J, Wise MP, Nilsson F, Cronberg T.

2013-10-1214 citations

10.1186/1471-2261-13-85

Interventions

OTHERTemperature treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

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

Exclusion criteria

at time for inclusion in the TTM study: * 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 * 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 Additional

Design outcomes

Primary

Measure	Time frame	Description
Rivermead Behavioural Memory Test (RBMT)	180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI)	Memory test
Frontal Assessment Battery (FAB)	180 days after CA or MI	Screening of Executive functions
Symbol Digit Modalities Test (SDMT)	180 days after CA or MI	Assess attention, mental speed and concentration

Secondary

Measure	Time frame	Description
Hospital Anxiety and Depression rating Scale (HADS)	180 days after CA or MI	Anxiety and Depression questionnaire
Two Simple Questions (TSQ)	180 days after CA or MI	Self rating of everyday activities and cognition
Informant Questionnaire on Cognitive Decline (IQCODE)	180 days after CA or MI	Patients cognitive functioning in everyday life, questionnaire completed by informant/relative/caregiver
Mayo-Portland Adaptability Inventory-4 (MPAI-4)	180 days after CA or MI	Self rating of impairments, adjustment, and participation (in the society)
Cerebral Performance Category (CPC)	180 days after CA or MI	Scale for general neurological outcome
modified Rankin Scale	180 days after CA or MI	Scale for general outcome
MiniMental Status Examination (MMSE)	180 days after CA or MI	General cognitive screening
Short-Form Questionnaire 36 version 2 (SF-36v2)	180 days after CA or MI	Questionnaire of health-related quality of life, both for patient and informant/relative/caregiver
Zarit Burden Interview	180 days after CA or MI	Questionnaire for caregiver/informant/relative's perception of burden

Countries

Denmark, Italy, Netherlands, Sweden, United Kingdom

Outcome results

None listed