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Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Temperature treatment
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Arrest focused on measuring Induced hypothermia, Mild induced hypothermia, Resuscitation, Therapeutic hypothermia, Neurological function, Cardiovascular diseases, Rehabilitation, Quality of life, Cognition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Exclusion criteria for the sub-study:

  • Disability to speak the site language well enough to complete tests without interpreter
  • Controls should never have suffered a cardiac arrest

Sites / Locations

  • Rigshospitalet
  • San Martino Hospital
  • Santa Maria degli Angeli Hospital
  • Ospedale Universitario di Cattinaria
  • Academisch Medisch Centrum (AMC)
  • Onze Lieve Vrouwe Gasthuis
  • Rijnstate Hospital
  • Leeuwarden Hospital
  • Sahlgrenska University Hospital, Thorax
  • Sahlgrenska University Hospital, Östra
  • Sahlgrenska University Hospital
  • Helsingborg Hospital
  • Karlstad Central Hospital
  • Skåne University Hospital, Lund
  • Skåne University Hospital, Malmö
  • Örebro University Hospital
  • Royal Bournemouth Hospital
  • University Hospital of Wales
  • St Georges' Hospital
  • Royal Berkshire NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cardiac Arrest 33°

Cardiac Arrest survivors 36°

Arm Description

survivors with temperature treatment 33°

survivors with temperature treatment 36°

Outcomes

Primary Outcome Measures

Rivermead Behavioural Memory Test (RBMT)
Memory test
Frontal Assessment Battery (FAB)
Screening of Executive functions
Symbol Digit Modalities Test (SDMT)
Assess attention, mental speed and concentration

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2013
Last Updated
December 4, 2013
Sponsor
Region Skane
Collaborators
Lund University, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Copenhagen University Hospital, Denmark, Azienda Ospedaliera Santa Maria Degli Angeli, Copenhagen Trial Unit, Center for Clinical Intervention Research, University Hospital of Wales
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1. Study Identification

Unique Protocol Identification Number
NCT01946932
Brief Title
Cognitive Impairment Following Cardiac Arrest and Target Temperature Management
Official Title
Cognitive Impairment Following Cardiac Arrest and Target Temperature Management
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Lund University, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Copenhagen University Hospital, Denmark, Azienda Ospedaliera Santa Maria Degli Angeli, Copenhagen Trial Unit, Center for Clinical Intervention Research, University Hospital of Wales

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
287 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac Arrest 33°
Arm Type
Active Comparator
Arm Description
survivors with temperature treatment 33°
Arm Title
Cardiac Arrest survivors 36°
Arm Type
Active Comparator
Arm Description
survivors with temperature treatment 36°
Intervention Type
Other
Intervention Name(s)
Temperature treatment
Primary Outcome Measure Information:
Title
Rivermead Behavioural Memory Test (RBMT)
Description
Memory test
Time Frame
180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI)
Title
Frontal Assessment Battery (FAB)
Description
Screening of Executive functions
Time Frame
180 days after CA or MI
Title
Symbol Digit Modalities Test (SDMT)
Description
Assess attention, mental speed and concentration
Time Frame
180 days after CA or MI
Secondary Outcome Measure Information:
Title
Mayo-Portland Adaptability Inventory-4 (MPAI-4)
Description
Self rating of impairments, adjustment, and participation (in the society)
Time Frame
180 days after CA or MI
Title
Short-Form Questionnaire 36 version 2 (SF-36v2)
Description
Questionnaire of health-related quality of life, both for patient and informant/relative/caregiver
Time Frame
180 days after CA or MI
Title
Zarit Burden Interview
Description
Questionnaire for caregiver/informant/relative's perception of burden
Time Frame
180 days after CA or MI
Title
Hospital Anxiety and Depression rating Scale (HADS)
Description
Anxiety and Depression questionnaire
Time Frame
180 days after CA or MI
Title
Two Simple Questions (TSQ)
Description
Self rating of everyday activities and cognition
Time Frame
180 days after CA or MI
Title
Informant Questionnaire on Cognitive Decline (IQCODE)
Description
Patients cognitive functioning in everyday life, questionnaire completed by informant/relative/caregiver
Time Frame
180 days after CA or MI
Title
MiniMental Status Examination (MMSE)
Description
General cognitive screening
Time Frame
180 days after CA or MI
Title
Cerebral Performance Category (CPC)
Description
Scale for general neurological outcome
Time Frame
180 days after CA or MI
Title
modified Rankin Scale
Description
Scale for general outcome
Time Frame
180 days after CA or MI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion criteria for the sub-study: Disability to speak the site language well enough to complete tests without interpreter Controls should never have suffered a cardiac arrest
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Cronberg, MD, PhD
Organizational Affiliation
Department of Clinical Sciences, Lund University, Lund, Sweden and Department of Neurology, Skåne University Hospital, Lund, Sweden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Niklas Nielsen, MD,PhD
Organizational Affiliation
Department of Clinical Sciences, Lund University, Lund Sweden and Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jesper Kjaergaard, MD, PhD
Organizational Affiliation
The Heart Centrem Copenhagen University, Copenhagen, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janneke Horn, MD, PhD
Organizational Affiliation
Department of Intensive Care, Academic Medical Centrum, Amsterdam, Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tommaso Pellis, MD, PhD
Organizational Affiliation
Intensive Care Unit Santa Maria Degli Angeli, Pordenonde, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew P Wise, MD, PhD
Organizational Affiliation
Adult Critical Care, University Hospital of Wales, Cardiff, Untied Kingdom
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gisela Lilja, OT
Organizational Affiliation
Lund University Hospital, Lund, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
San Martino Hospital
City
Genova
Country
Italy
Facility Name
Santa Maria degli Angeli Hospital
City
Pordenone
Country
Italy
Facility Name
Ospedale Universitario di Cattinaria
City
Trieste
Country
Italy
Facility Name
Academisch Medisch Centrum (AMC)
City
Amsterdam
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
Country
Netherlands
Facility Name
Rijnstate Hospital
City
Arnhem
Country
Netherlands
Facility Name
Leeuwarden Hospital
City
Leeuwarden
Country
Netherlands
Facility Name
Sahlgrenska University Hospital, Thorax
City
Gothenburg
Country
Sweden
Facility Name
Sahlgrenska University Hospital, Östra
City
Gothenburg
Country
Sweden
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Facility Name
Helsingborg Hospital
City
Helsingborg
Country
Sweden
Facility Name
Karlstad Central Hospital
City
Karlstad
Country
Sweden
Facility Name
Skåne University Hospital, Lund
City
Lund
Country
Sweden
Facility Name
Skåne University Hospital, Malmö
City
Malmoe
Country
Sweden
Facility Name
Örebro University Hospital
City
Örebro
Country
Sweden
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Facility Name
St Georges' Hospital
City
London
Country
United Kingdom
Facility Name
Royal Berkshire NHS Foundation Trust
City
Reading
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19631442
Citation
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.
Results Reference
background
PubMed Identifier
22520518
Citation
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.
Results Reference
background
PubMed Identifier
36164471
Citation
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.
Results Reference
derived
PubMed Identifier
29326145
Citation
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.
Results Reference
derived
PubMed Identifier
26433116
Citation
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.
Results Reference
derived
PubMed Identifier
25681466
Citation
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.
Results Reference
derived
PubMed Identifier
24118853
Citation
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.
Results Reference
derived

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Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

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