None listed
Conditions
Brief summary
The TAME Cardiac Arrest trial will study the ability of higher carbon dioxide (CO2) levels to reduce brain damage, comparing giving patients ‘normal’ to ‘slightly higher than normal’ blood CO2 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 ICU. This therapy is cost free and, if shown to be effective, will improve thousands of Australian lives, transform clinical practice, and yield major savings.
Interventions
Patients allocated to the targeted therapeutic mild hypercapnia protocol will be sedated as per unit gudelines and at the clinical discretion of the treating intensive care doctors 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 for 24 hours follow
Patients allocated to the targeted therapeutic mild hypercapnia protocol will be sedated as per unit gudelines and at the clinical discretion of the treating intensive care doctors 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 for 24 hours following randomisation.. Arterial blood gases will be repeated every 4 hours for 24 hours following randomisation or if end-tidal carbon dioxide values change >5 mmHg. Adjustments to be made to the minute ventilation in order to stay within the target PaCO2 range will be made at the clinical discretion of the treating intensive care doctors. Strategies to monitor adherence to the target PaCO2 range will be via respiratory rate monitoring that displays a continuous record of PaCo2 values and as recorded on the participant's physiological observation chart while in the intensive care unit.
Sponsors
A/Prof Glenn Eastwood
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult (greater than or equal to 18 years of age) Out-of-hospital cardiac arrest of a presumed cardiac or unknown cause Sustained return of spontaneous circulation - defined as 20 minutes with signs of circulation without the need for chest compressions Unconscious (FOUR-score motor response of less than 4, not able to obey veral commands after sustained return of spontaenous circulation Eligible for intensive care without restrictions or limitations Within less than 180 minutes of return of spontaneous circulation
Exclusion criteria
Unwitnessed cardiac arrest with an initial rhythm of asystole Temperature on admission of less than 30oC On extracorporeal membrane oxygenation prior to return of spontaneous circiulation Obvious or suspected pregnancy Intracranial bleeding Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy
Outcome results
None listed