Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03114033




Registration number
NCT03114033
Ethics application status
Date submitted
11/04/2017
Date registered
14/04/2017
Date last updated
20/04/2022

Titles & IDs
Public title
Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest
Scientific title
TAME Cardiac Arrest Trial: Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest: A Phase III Multi-Centre Randomised Controlled Trial
Secondary ID [1] 0 0
ANZIC-RC/SB001
Universal Trial Number (UTN)
Trial acronym
TAME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Out-Of-Hospital Cardiac Arrest 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Targeted therapeutic mild hypercapnia
Other interventions - Targeted normocapnia (Standard care)

Experimental: Targeted therapeutic mild hypercapnia - Target arterial carbon dioxide range of 50-55 mmHg for 24 hours following randomisation

Active Comparator: Targeted normocapnia (Standard care) - Target arterial carbon dioxide range of 35-45 mmHg for 24 hours following randomisation


Other interventions: 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 interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Neurological outcome
Timepoint [1] 0 0
6 months following enrolment
Secondary outcome [1] 0 0
Mortality at intensive care unit discharge
Timepoint [1] 0 0
6 months after randomisation
Secondary outcome [2] 0 0
Mortality at hospital discharge
Timepoint [2] 0 0
6 months after randomisation
Secondary outcome [3] 0 0
Health-related Quality of Life (EQ-5D-5L)
Timepoint [3] 0 0
6 months after randomisation
Secondary outcome [4] 0 0
modified Rankin scale (mRS)
Timepoint [4] 0 0
6 months after randomisation
Secondary outcome [5] 0 0
Montreal Cognitive Assessment (MoCA-blind)
Timepoint [5] 0 0
6 months after randomisation
Secondary outcome [6] 0 0
Mortality at 6 months
Timepoint [6] 0 0
6 months after randomisation
Secondary outcome [7] 0 0
Informant Questionnaire on Cognitive Decline in the Elderly-Cardiac Arrest (IQCODE)
Timepoint [7] 0 0
6 months after randomisation
Secondary outcome [8] 0 0
Symbol Digit Modality Test
Timepoint [8] 0 0
6 months after randomisation

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
Accrual to date
Final
1700
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Nepean Hospital - Penrith
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [5] 0 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [8] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [9] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [10] 0 0
Nambour Hospital - Sunshine Coast
Recruitment hospital [11] 0 0
Sunshine Coast University Hospital - Sunshine Coast
Recruitment hospital [12] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [13] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [14] 0 0
The Northern Hospital - Epping
Recruitment hospital [15] 0 0
University Hospital Geelong - Geelong
Recruitment hospital [16] 0 0
Alfred Health - Melbourne
Recruitment hospital [17] 0 0
Footscray Hospital-Western Health - Melbourne
Recruitment hospital [18] 0 0
Sunshine Hospital-Western Health - Melbourne
Recruitment hospital [19] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [20] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2750 - Penrith
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
0810 - Tiwi
Recruitment postcode(s) [6] 0 0
4029 - Brisbane
Recruitment postcode(s) [7] 0 0
4102 - Brisbane
Recruitment postcode(s) [8] 0 0
4032 - Chermside
Recruitment postcode(s) [9] 0 0
4215 - Southport
Recruitment postcode(s) [10] 0 0
4560 - Sunshine Coast
Recruitment postcode(s) [11] 0 0
4575 - Sunshine Coast
Recruitment postcode(s) [12] 0 0
3929 - Adelaide
Recruitment postcode(s) [13] 0 0
3350 - Ballarat
Recruitment postcode(s) [14] 0 0
3076 - Epping
Recruitment postcode(s) [15] 0 0
- Geelong
Recruitment postcode(s) [16] 0 0
3004 - Melbourne
Recruitment postcode(s) [17] 0 0
3011 - Melbourne
Recruitment postcode(s) [18] 0 0
3021 - Melbourne
Recruitment postcode(s) [19] 0 0
3050 - Melbourne
Recruitment postcode(s) [20] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Genk
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Denmark
State/province [4] 0 0
Aarhus
Country [5] 0 0
Finland
State/province [5] 0 0
Helsinki
Country [6] 0 0
France
State/province [6] 0 0
Franche Comte
Country [7] 0 0
Ireland
State/province [7] 0 0
Dublin
Country [8] 0 0
Ireland
State/province [8] 0 0
Galway
Country [9] 0 0
Italy
State/province [9] 0 0
Milan
Country [10] 0 0
Netherlands
State/province [10] 0 0
Amsterdam
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland
Country [12] 0 0
New Zealand
State/province [12] 0 0
Christchurch
Country [13] 0 0
New Zealand
State/province [13] 0 0
Wellington
Country [14] 0 0
New Zealand
State/province [14] 0 0
Rotorua
Country [15] 0 0
Norway
State/province [15] 0 0
Oslo
Country [16] 0 0
Saudi Arabia
State/province [16] 0 0
Riyadh
Country [17] 0 0
Slovenia
State/province [17] 0 0
Maribor
Country [18] 0 0
Sweden
State/province [18] 0 0
Helsingborg
Country [19] 0 0
Sweden
State/province [19] 0 0
Malmö
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Portsmouth
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Belfast
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Birmingham
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Bournemouth
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Bristol
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Cardiff
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Manchester
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Reading

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Health Research Board, Ireland
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03114033
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Glenn M Eastwood, RN, PhD
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03114033