Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

Not Applicable

Completed

• Conditions: Cognition Disorders; Brain Injury; Out-of-hospital Cardiac Arrest; Heart Arrest
• Interventions: Other: Temperature treatment

• Registration Number: NCT01946932
• Lead Sponsor: Region Skane

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Status Verified: 2013-08
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-12-04
• Last Update Posted: 2013-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac Arrest 33°	Temperature treatment	survivors with temperature treatment 33°
Cardiac Arrest survivors 36°	Temperature treatment	survivors with temperature treatment 36°

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mayo-Portland Adaptability Inventory-4 (MPAI-4)	180 days after CA or MI	Self rating of impairments, adjustment, and participation (in the society)
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
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
MiniMental Status Examination (MMSE)	180 days after CA or MI	General cognitive screening
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

Trial Locations

Locations (20)

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands

Leeuwarden Hospital; 🇳🇱 Leeuwarden, Netherlands

Ospedale Universitario di Cattinaria; 🇮🇹 Trieste, Italy

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

St Georges' Hospital; 🇬🇧 London, United Kingdom

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Helsingborg Hospital; 🇸🇪 Helsingborg, Sweden

Skåne University Hospital, Lund; 🇸🇪 Lund, Sweden

University Hospital of Wales; 🇬🇧 Cardiff, United Kingdom

Royal Berkshire NHS Foundation Trust; 🇬🇧 Reading, United Kingdom

Sahlgrenska University Hospital, Thorax; 🇸🇪 Gothenburg, Sweden

Sahlgrenska University Hospital, Östra; 🇸🇪 Gothenburg, Sweden

Karlstad Central Hospital; 🇸🇪 Karlstad, Sweden

Skåne University Hospital, Malmö; 🇸🇪 Malmoe, Sweden

San Martino Hospital; 🇮🇹 Genova, Italy

Santa Maria degli Angeli Hospital; 🇮🇹 Pordenone, Italy

Academisch Medisch Centrum (AMC); 🇳🇱 Amsterdam, Netherlands

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Örebro University Hospital; 🇸🇪 Örebro, Sweden