The TAME Study

The TAME trial is a phase III, multi-centre, randomised, parallel-group, clinical trial in resuscitated cardiac arrest patients admitted to the intensive care unit to determine whether targeted therapeutic mild hypercapnia (TTMH) improves neurological outcome at 6 months compared to standard care (targeted normocapnia) (TN).

The TAME Study

Background

  • For patients admitted to the ICU after a cardiac arrest, neurological injury leading to the withdrawal of life support or neurological impairment are the most common outcomes following cardiac arrest.
  • Even after the heart has been restarted, poor blood flow to the brain continues and can cause more brain injury.
  • A likely reason for this loss of blood flow after the heart has been restarted is the loss of the normal ability of brain blood vessels to adjust blood flow (autoregulation): a process controlled by carbon dioxide in the blood.
  • However, an increased partial pressure of carbon dioxide (PaCO2) in the blood (hypercapnia) could increase brain blood flow in these patients. This treatment, compared to standard care, will hopefully meet the needs of the brain and reduce damage.

Facts

  • An out-of-hospital cardiac arrest has an estimated incidence of approximately 1 per 1,000 persons per year (approximately 25,000 individuals in Australia each year).
  • Australian mortality rates for heart attack range between 87-94%.
  • For each resuscitated cardiac arrest patient admitted to ICU who survives to hospital discharge, admission costs alone exceed $120,000. Moreover, the estimated ongoing community-based costs for each patient with moderate cerebral injury is AUD$34,000/year.

Aim

  • The primary objective of this study is to determine whether targeted therapeutic mild hypercapnia (TTMH) improves neurological outcome at 6 months compared to standard care (targeted normocapnia) (TN).

Methods

  • A 1700 patient, an international, multi-centre, parallel-group, phase III, non-commercial, randomised, controlled trial (RCT).
  • Eligible patients will be randomised 1:1 to receive targeted therapeutic mild hypercapnia (TTMH) treatment with the target PaCO2 range of 50-55 mmHg for 24 hours, or standard care (targeted normocapnia [TN]) with the target PaCO2 range of 35-45 mmHg for 24 hours.

Endorsement: Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS-CTG) and the Irish Critical Care – Clinical Trials Group (ICC-CTG)

Coordinating centre: The ANZIC-RC, School of Public Health and Preventative Medicine, Monash University

Chief Investigator: Associate Professor Glenn Eastwood RN BN BN(Hons) GDipNurs(CritCare) PhD.

ContactAssociate Professor Glenn Eastwood, Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria 3084, Australia. Phone: +61 3 9496 4835 Fax: +61 3 9496 3932 Email: glenn.eastwood@austin.org.au

Twitter: Follow news and updates from the TAME trial page on Twitter – https://twitter.com/TAMEtrial

Software: Spinnaker, Spiral Software

Download the TAME Fact Sheet (.pdf)

Twitter

Read what people are saying about the TAME Trial on Twitter

#TAMEtrial

Read what people are saying about the TAME Trial on Twitter.
#TAMEtrial

Study Database

Sign in to the study (username + password needed)

Study Database

The TAME Trial is currently being built. If you have a username and password you can sign in from here.
Study Database

ANZCTR

View this trial on the Australian and New Zealand Clinical Trial Registry

ANZCTR

View this trial on the Australian and New Zealand Clinical Trial Registry. 
ACTRN12617000036314p