Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000436471
Ethics application status
Approved
Date submitted
15/02/2007
Date registered
29/08/2007
Date last updated
29/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cerebral Oximetry in Cardiac Surgery
Scientific title
Using Cerebral oximetry (INVOS 5100) during cardiopulmonary bypass in patients requiring elective isolated coronary artery bypass graft surgery to improve neuropsychological outcomes or composite clincal outcomes (composite endpoint based on the presence of 30-day mortality or a major morbidity (permanent stroke, renal dysfunction or failure, cardiac surgery reoperation, prolonged ventilation, deep sternal wound infection)).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients cerebral oxygenation during cardiopulmonary bypass 2128 0
Condition category
Condition code
Cardiovascular 2224 2224 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4 groups, with blinded or unblinded operator with respect to cerebral oximetry monitor and unblinded operator with respect to rewarming rate. Group 1: Standard rewarming with blinded near infrared spectroscopy (control)
Group 2: Standard rewarming with interventional near infrared spectroscopy
Group 3: Slow rewarming with blinded near infrared spectroscopy
Group 4: Slow rewarming with interventional near infrared spectroscopy

Cerebral monitoring occurs from time immediately prior to intubation to the time the patient is extubated (12-15 hr).

Standard rewarming is when the patient is rewarmed at a maximum rate of 1 degree per minute, slow rewarming is when the patient is rewwarmed at a maximum rate 0.5C per minute. INVOS Cerebral Oximeter interventions include increasing flow, gas sweep rates, cardiac output, oxygen saturation and hematocrit.

Blinded near infrared spectroscopy is when the perfusionist is unaware of what the spectrocopy results are during the oepration (equivalent to current practice), interventional is when the perfusionist uses the interventiones noted above to manage the perfusion based upon the near infra red spctrcopy results.

The device is called teh INVOS cerebral oximeter, details are avaialble on the follwoing website http://www.somanetics.com/invos.htm. INVOS means "In-Vivo Optical Spectroscopy".
Intervention code [1] 1606 0
Treatment: Devices
Comparator / control treatment
Group 1: Standard rewarming with blinded near infrared spectroscopy (control)
Control group
Active

Outcomes
Primary outcome [1] 3084 0
Neuropsychological outcome measures (including Employment Status; Edinburgh Handedness; Orientation;California Verbal Learning Test-II; Purdue Pegboard ; Verbal Fluency (COWAT); Trails Making Test A & B; Symbol Digit; Boston Naming Test short form: or Cognitive Drug Research test battery)
Timepoint [1] 3084 0
Reported prior to discharge and 6,12 and 24 month postoperatively. For patients who do not complete neuropsychological assessments, the combined clinical endpoint will serve as primary outcome (a composite endpoint based on the presence of 30-day mortality or a major morbidity (permanent stroke, renal dysfunction or failure, cardiac surgery reoperation, prolonged ventilation, deep sternal wound infection) determined at discharge.
Secondary outcome [1] 5501 0
Secondary outcomes 1: combined clinical endpoint, a composite endpoint based on the presence of 30-day mortality or a major morbidity (permanent stroke, renal dysfunction or failure, cardiac surgery reoperation, prolonged ventilation, deep sternal wound infection) occurring during the period of hospitalisation.
Timepoint [1] 5501 0
30 day or until end of hospitalisation
Secondary outcome [2] 5502 0
In addition Short Portable Mental Status Questionnaire, Medical Outcome Short Form 36 Health Survey, Delerium Symptom Interview, Depression Anxiety Sress Scale, Mood Anxiety Sress-Questionairre, Mini International Neuropsychiatirc Interview and a clinical assessment are performed at discharge, 6, 12 and 24 months.

A clinical assessment is the routine morbidity and health examination that is performed on all patients prior to discharge.
Timepoint [2] 5502 0
Prior to discharge.

Eligibility
Key inclusion criteria
The patient sample: will consist of participants of both gender, requiring elective isolated coronary artery bypass graft surgery at Flinders Medical Centre;
The patient is willing to participate and has signed a consent form.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
English not first language;
Previous cerebrovascular disease including CVA, RIND, or TIA anytime prior to planned surgery;
Emergency and urgent coronary artery surgery
Previous open heart surgery
History of neurological disease/insult

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
2. Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Surgeon who performs the operation is blinded to the oximetry; data collector (medical officer) is blinded to the both the oximetry and teh rewarming strategy. The perfusionist is unblinded to the randomisation, as is the trial co-ordinator.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2384 0
Charities/Societies/Foundations
Name [1] 2384 0
National Heart Foundation
Country [1] 2384 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Country
Australia
Secondary sponsor category [1] 2158 0
None
Name [1] 2158 0
none
Address [1] 2158 0
Country [1] 2158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4210 0
Flinders Medical Centre
Ethics committee address [1] 4210 0
Ethics committee country [1] 4210 0
Australia
Date submitted for ethics approval [1] 4210 0
Approval date [1] 4210 0
19/02/2007
Ethics approval number [1] 4210 0
105-067

Summary
Brief summary
Cardiac surgery is a very common procedure for the treatment of coronary artery disease, however it is not without side effects. Some of these complications, such as stroke, are overtly debilitating, whilst others such as mood changes are less obvious, but still affect daily activities. The aetiology of these complications remains unclear. We believe that they arise from many different causes, some of which relate to the cardiopulmonary bypass machine that is used to support patients during heart surgery. We propose to investigate a device that will help us determine if the brain is being correctly protected during heart surgery using cardiopulmonary bypass. We plan to utilise this device to continuously monitor the amount of oxygen that is supplied to the brain during heart surgery. In addition, we will combine monitoring of the brain with therapeutic strategies designed to limit the exposure of the brain to potentially harmful events. Ultimately this information could be used to reduce the incidence of postoperative brain complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27540 0
Address 27540 0
Country 27540 0
Phone 27540 0
Fax 27540 0
Email 27540 0
Contact person for public queries
Name 10795 0
Robert A Baker
Address 10795 0
Flinders Medical Centre
Country 10795 0
Australia
Phone 10795 0
61884042015
Fax 10795 0
Email 10795 0
[email protected]
Contact person for scientific queries
Name 1723 0
Robert A Baker
Address 1723 0
Flinders Medical Centre
Country 1723 0
Australia
Phone 1723 0
61884042015
Fax 1723 0
Email 1723 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
No documents have been uploaded by study researchers.

Documents added automatically
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