Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

Region Skane

Status: Completed

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

Treatments: Other: Temperature treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01946932

TTMcogsub

Details and patient eligibility

About

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.

Enrollment: 287 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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287 participants in 2 patient groups

Cardiac Arrest 33°

Active Comparator group

Description:

survivors with temperature treatment 33°

Treatment:

Other: Temperature treatment

Cardiac Arrest survivors 36°

Active Comparator group

Description:

survivors with temperature treatment 36°

Treatment:

Other: Temperature treatment