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Trial registered on ANZCTR


Registration number
ACTRN12609000844246
Ethics application status
Not yet submitted
Date submitted
25/09/2009
Date registered
30/09/2009
Date last updated
30/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial investigating carbon dioxide insufflation of the pericardial field as a neuroprotective strategy in open chamber cardiac surgery.
Scientific title
'A randomised controlled trial investigating the effect of carbon dioxide insufflation of the pericardial field as a neuroprotective strategy to decrease postoperative neurocognitive impairment in patients undergoing open chamber cardiac surgery.'
Universal Trial Number (UTN)
U1111-1111-9992
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurocognitive impairment post cardiac surgery 251919 0
Condition category
Condition code
Mental Health 252097 252097 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Carbon dioxide insufflation of the pericardial field intraoperatively which involves blowing carbon dioxide gas into the chest cavity only during the cardiac surgery operation via a tube. It will be continuously insufflated at 10 Litre/minute from the opening of the cardiac chamber until the closure of the cardiac chamber. This tube is connected to a device called CarbonAid gas diffuser device (K052125)
Intervention code [1] 241338 0
Treatment: Other
Intervention code [2] 241339 0
Prevention
Comparator / control treatment
The standard treatment for removing air from the cardiac chambers is mechanical deairing manouevres performed only during the operation. These manouvres are performed continuously before the aortic cross clamp is removed and may take 5 to 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 252978 0
Neurocognitive impairment
-defined by scores on a battery of neurocognitive tests including Rey auditory verbal learning test, Trail-making A, Trail-making B and Grooved pegboard test.
Timepoint [1] 252978 0
-Once preoperatively
-Once postoperatively at 2 to 3 months
Secondary outcome [1] 257737 0
Transoesophagel Echocardiography (TOE)
- intraoperative assessment of resdiual intracardiac air and gaseous emboli using an ultrasound probe which is routinely passed through the oesophagus during cardiac surgery operations to look at the heart
Timepoint [1] 257737 0
-Intraoperative
Secondary outcome [2] 257738 0
S100B blood tests
- postulated surrogate marker for neurocognitive impairment
- 10mls sample of blood taken with routine blood tests after an operation which will be analysed in a pathology laboratory assay
Timepoint [2] 257738 0
-Preoperative
-Postoperative within 24 hours
Secondary outcome [3] 257739 0
P300 Auditory Evoked Potential
- postulated surrogate marker for neurocognitive impairment
- similar to a EEG (Electroencephalogram) where brain waves are monitored to determine the latency of a P300 wave
Timepoint [3] 257739 0
Once preoperatively, once prior to discharge, and once 2 to 3 months postoperatively.

Eligibility
Key inclusion criteria
Undergoing an open cardiac (aortic and/or mitral valve) operation; competence to provide informed consent;ability to communicate in English to undertake the neuropsychological test
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Past history of cerebrovascular accident (stroke or Transient Ischemic Attack (TIA));history of clinically diagnosed active psychiatric conditions; emergency or salvage cardiac valve operations; Intelligence Quotient < 70

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243791 0
Hospital
Name [1] 243791 0
The Alfred Hospital
Country [1] 243791 0
Australia
Primary sponsor type
Hospital
Name
Department of Cardiothoracic Surgery
Address
The Alfred Hospital,
Commercial Road,
Melbourne,
VIC 3004
Country
Australia
Secondary sponsor category [1] 237145 0
Hospital
Name [1] 237145 0
The Alfred Hospital
Address [1] 237145 0
Commercial Road,
Melbourne,
VIC 3004
Country [1] 237145 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 243919 0
The Alfred Human Research Ethics Committee
Ethics committee address [1] 243919 0
The Alfred Ethics Office,
Second Floor East Block,
The Alfred Hospital,
Commercial Road,
Melbourne VIC 3004
Ethics committee country [1] 243919 0
Australia
Date submitted for ethics approval [1] 243919 0
30/09/2009
Approval date [1] 243919 0
Ethics approval number [1] 243919 0
1/09/0361

Summary
Brief summary
The primary purpse of the study is to determine if blowing carbon dioxide gas into the chest cavity during a cardiac surgery operation involving the heart valves protects against the decrease in mental function that occurs following these operations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30330 0
Address 30330 0
Country 30330 0
Phone 30330 0
Fax 30330 0
Email 30330 0
Contact person for public queries
Name 13577 0
Dr Krishanu Chaudhuri
Address 13577 0
Department of Cardiothoracic Surgery,
The Alfred Hospital,
Commercial Road,
Melbourne
VIC 3004
Country 13577 0
Australia
Phone 13577 0
+61 3 90762000
Fax 13577 0
Email 13577 0
[email protected]
Contact person for scientific queries
Name 4505 0
A/Prof Silvana Marasco
Address 4505 0
Department of Cardiothoracic Surgery,
The Alfred Hospital,
Commercial Road,
Melbourne
VIC 3004
Country 4505 0
Australia
Phone 4505 0
+61 3 90762000
Fax 4505 0
Email 4505 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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