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TAME Cardiac Arrest Trial. Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest: A Phase III Multi-Centre Randomised Controlled Trial

Phase 3
Completed
Conditions
Postanoxic encephalopathy
brain injury after cardiac arest
10007521
10014623
Registration Number
NL-OMON46761
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
150
Inclusion Criteria

1. Adult (age *18 years or older)
2. Out-of-hospital cardiac arrest of a presumed cardiac or unknown cause
3. Sustained ROSC * defined as 20 minutes with signs of circulation without the need for chest compressions
4. Unconscious (FOUR-score motor response of <4, not able to obey verbal commands after sustained ROSC)
5. Eligible for intensive care without restrictions or limitations
6. Within <180 minutes of ROSC

Exclusion Criteria

1. Unwitnessed cardiac arrest with an initial rhythm of asystole
2. Temperature on admission <30 C
3. On ECMO prior to ROSC
4. Obvious or suspected pregnancy
5. Intracranial bleeding
6. Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary outcome measure for this study is the proportion of patients with a<br /><br>favourable neurological outcome at 6 months as assessed using the GOSE.</p><br>
Secondary Outcome Measures
NameTimeMethod
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