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Targeted Therapeutic Mild Hyp...

Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest

Last Updated: 2022-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

Total Enrollment

1700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Cardiac arrest is a common and catastrophic event with substantial human and financial costs. It is well understood that cardiac arrest leads to brain injury. However, what is not widely appreciated is that, after circulation has been restored, cerebral hypoperfusion continues. Ongoing cerebral vasoconstriction and cerebral hypoxia has been demonstrated using technologies that include positron emission tomography, ultrasound, jugular bulb oxygen saturation and cerebral oximetry.

A likely mechanism responsible for sustained early cerebral hypoperfusion relates to impaired cerebrovascular auto-regulation. Such impaired cerebral auto-regulation may make even a normal arterial carbon dioxide tension (PaCO2) (the major physiological regulator of cerebral blood flow) insufficient to achieve and maintain adequate cerebral perfusion and, consequently, cerebral oxygenation. However, PaCO2 is the major determinant of cerebral blood flow and an increased PaCO2 (hypercapnia) markedly increases cerebral blood flow. Moreover, arterial carbon dioxide is modifiable and, as such, is a potential therapeutic target.

The TAME Cardiac Arrest Trial is a definitive phase III multi-centre randomised controlled trial in resuscitated cardiac arrest patients. This trial will determine whether targeted therapeutic mild hypercapnia (TTMH) applied during the first 24 hours of mechanical ventilation in the intensive care unit (ICU) improves neurological outcome at 6 months compared to standard care (targeted normocapnia (TN).

Supported by compelling preliminary data, significant improvements in patient outcomes are achievable with this proposed simple and cost free therapy. Recruiting 1,700 patients, for multiple sites in many countries, this will be the largest trial ever conducted involving resuscitated cardiac arrest patients admitted to the ICU. If the TAME Cardiac Arrest Trial confirms that TTMH is effective, its findings will improve the lives of many, transform clinical practice and yield major economic gains worldwide.

Conditions

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Out-Of-Hospital Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

A Randomised, Parallel Groups, Assessor Blinded, Clinical Trial

Study Groups

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Targeted therapeutic mild hypercapnia

Target arterial carbon dioxide range of 50-55 mmHg for 24 hours following randomisation

Group Type EXPERIMENTAL

Targeted therapeutic mild hypercapnia

Intervention Type OTHER

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

Targeted normocapnia (Standard care)

Target arterial carbon dioxide range of 35-45 mmHg for 24 hours following randomisation

Group Type ACTIVE_COMPARATOR

Targeted normocapnia (Standard care)

Intervention Type OTHER

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.

Interventions

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Targeted therapeutic mild hypercapnia

Intervention Type OTHER

Targeted normocapnia (Standard care)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unwitnessed cardiac arrest with an initial rhythm of asystole
* Temperature on admission \<30oC
* On ECMO prior to ROSC
* Obvious or suspected pregnancy
* Intracranial bleeding
* Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glenn M Eastwood, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Monash University

Locations

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St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Site Status

Nepean Hospital

Penrith, New South Wales, Australia

Site Status

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Site Status

Wollongong Hospital

Wollongong, New South Wales, Australia

Site Status

Royal Darwin Hospital

Tiwi, Northern Territory, Australia

Site Status

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Site Status

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Site Status

Prince Charles Hospital

Chermside, Queensland, Australia

Site Status

Gold Coast University Hospital

Southport, Queensland, Australia

Site Status

Nambour Hospital

Sunshine Coast, Queensland, Australia

Site Status

Sunshine Coast University Hospital

Sunshine Coast, Queensland, Australia

Site Status

Flinders Medical Centre

Adelaide, South Australia, Australia

Site Status

Ballarat Base Hospital

Ballarat, Victoria, Australia

Site Status

The Northern Hospital

Epping, Victoria, Australia

Site Status