Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000648426
Ethics application status
Not yet submitted
Date submitted
15/12/2007
Date registered
20/12/2007
Date last updated
20/12/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Fundoscopy to assess evidence of microvascular thrombosis in cardiac surgery
Scientific title
Fundoscopy to assess evidence of microvascular thrombosis in cardiac surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Changes in microcirculation post cardiac surgery 2631 0
Condition category
Condition code
Inflammatory and Immune System 2747 2747 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Right pupil will be dilated with 1 drop of 0.1% tropicamide eye drops. Retinal and macular photographs will be taken pre-operatively and post-operatively
Intervention code [1] 2367 0
Not applicable
Comparator / control treatment
No Control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3636 0
To assess changes eg emboli and inflammatory changs in the retinal circulation post cardiac surgery. No other instruments besides retinal photographs will be used
Timepoint [1] 3636 0
1 day post operatively
Secondary outcome [1] 6096 0
The retinal photographs will be assessed by researchers in ophthalmology who will measure the diameter and patency of the retinal blood vessels. Secondary outcomes may be any other incidental changes in the retina, such as evidence of oedema, post cardiac surgery.
Timepoint [1] 6096 0
1 day post operatively

Eligibility
Key inclusion criteria
Patients undergoing cardiac surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous cardiac surgery; eye disease; patient refusal; type 1 Diabetes Mellitus

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 340 0
3065

Funding & Sponsors
Funding source category [1] 2887 0
Hospital
Name [1] 2887 0
St Vincents Hospital
Country [1] 2887 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Hospital
Address
Victoria Parade
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 2607 0
None
Name [1] 2607 0
Address [1] 2607 0
Country [1] 2607 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4828 0
Ethics committee address [1] 4828 0
Ethics committee country [1] 4828 0
Date submitted for ethics approval [1] 4828 0
14/11/2007
Approval date [1] 4828 0
Ethics approval number [1] 4828 0

Summary
Brief summary
Cardiac surgery triggers an acute inflammatory response throughout the body that contributes to multiple organ failures. How this inflammatory response causes organ failures is not well understood. We have undertaken trials that demonstrate the formation of clots in small blood vessels (capillaries) maybe an important mechnanism.We would like to further investigate this mechanism of organ injury by studying the capillaries in the back of the eye (retina) to see if clots form there following cardiac surgery.

Unlike other parts of the body the capillaries of the retina can be seen using fundoscopy ( a special torch that focuses light on the retina).

We will use a fundoscopic camera to take pictures of the retina before and after cardiac surgery to asses the changes in the capillaries.

Taking pictures of the back of the eye will not expose patients to any risks.

The results of this trial may highlight a new and important mechanism of organ injury in inflammatory states.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28242 0
Address 28242 0
Country 28242 0
Phone 28242 0
Fax 28242 0
Email 28242 0
Contact person for public queries
Name 11399 0
Eilis Condon
Address 11399 0
St Vincents Hospital
Victoria Parade
Fitzroy VIC 3065
Country 11399 0
Australia
Phone 11399 0
+61 3 92884420
Fax 11399 0
Email 11399 0
[email protected]
Contact person for scientific queries
Name 2327 0
Eilis Condon
Address 2327 0
St Vincents Hospital
Victoria Parade
Fitzroy VIC 3065
Country 2327 0
Australia
Phone 2327 0
+61 3 92884420
Fax 2327 0
Email 2327 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
No additional documents have been identified.