Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest
NCT03114033 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1700
Last updated 2022-04-20
Summary
The TAME Cardiac Arrest trial will study the ability of higher arterial carbon dioxide (PaCO2) levels to reduce brain damage, comparing giving patients 'normal' to 'slightly higher than normal' blood PaCO2 levels and assessing their ability to return to normal life-tasks. It will be the largest trial ever conducted in heart attack patients in the intensive care unit. This therapy is cost free and, if shown to be effective, will improve thousands of lives, transform clinical practice, and yield major savings.
Conditions
- Out-Of-Hospital Cardiac Arrest
Interventions
- OTHER
-
Targeted therapeutic mild hypercapnia
Patients allocated to the TTMH protocol will be sedated to achieve moderate to deep sedation (a target Richmond Agitation Scale Score of -4). Arterial blood gases and end- tidal carbon dioxide levels will be measured at baseline and then used to guide respiratory rate adjustments of minute ventilation to remain within the target PaCO2 range of 50-55 mmHg. Arterial blood gases will be repeated every 4 hours for 24 hours following randomisation or if end-tidal carbon dioxide values change \>5 mmHg
- OTHER
-
Targeted normocapnia (Standard care)
Patients allocated to the standard care (TN) protocol will be managed according to current practice and in accordance with ILCOR guidelines which recommend maintaining normocapnia in these patients. They will be sedated to achieve moderate to deep sedation (a target Richmond Agitation Scale Score of - 4). Arterial blood gases and end-tidal carbon dioxide levels will be measured at baseline and then used to guide respiratory rate adjustments of minute ventilation to remain within the target PaCO2 range of 35-45 mmHg. Arterial blood gases will be repeated every 4 hours for 24 hours following randomisation or if end-tidal carbon dioxide values change \>5 mmHg.
Sponsors & Collaborators
-
National Health and Medical Research Council, Australia
collaborator OTHER -
Health Research Board, Ireland
collaborator OTHER -
Australian and New Zealand Intensive Care Research Centre
lead OTHER
Principal Investigators
-
Glenn M Eastwood, RN, PhD · Monash University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-15
- Primary Completion
- 2022-12-31
- Completion
- 2022-12-31
Countries
- Australia
- Belgium
- Denmark
- Finland
- France
- Ireland
- Italy
- Netherlands
- New Zealand
- Norway
- Saudi Arabia
- Slovenia
- Sweden
- United Kingdom
Study Locations
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