Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000006549
Ethics application status
Approved
Date submitted
4/01/2006
Date registered
4/01/2006
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of serotonin receptor antagonists on delirium after coronary artery bypass graft surgery.
Scientific title
The effect of serotonin receptor antagonists on delirium after coronary artery bypass graft surgery.
Universal Trial Number (UTN)
Trial acronym
SERIOUS-D: Serotonin Receptor Inhibition OUtcome after Surgery- Delirium
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post cardiac bypass delirium 967 0
Condition category
Condition code
Cardiovascular 1039 1039 0 0
Other surgery
Neurological 1040 1040 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive tropisetron in the first 5 post-operative days.

Investigating the use of tropisetron vs placebo on the incidence of post-cardiopulmonary bypass related delirium in the first 5 post-operative days. A pilot study of 100 patients in the early post-operative phase.
Intervention code [1] 821 0
Prevention
Comparator / control treatment
Participants will receive placebo in the first 5 post-operative days.
Control group
Placebo

Outcomes
Primary outcome [1] 1391 0
Post-cardiopulmonary bypass related delirium
Timepoint [1] 1391 0
Up to 5 days post-operatively
Secondary outcome [1] 2456 0
Cardiovascular support
Timepoint [1] 2456 0
Secondary outcome [2] 2457 0
Intensive care unit length of stay
Timepoint [2] 2457 0
Secondary outcome [3] 2458 0
Hospital length of stay.
Timepoint [3] 2458 0

Eligibility
Key inclusion criteria
All patients undergoing coronary artery bypass graft (CABG) surgery, requiring cardiopulmonary bypass (CPB).
Minimum age
60 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing delirium, drug/alcohol abuse, age<60 years, haemodynamic instability pre-operatively, acute or evolving myocardial ischaemia.

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)
Randomised independently sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1139 0
Hospital
Name [1] 1139 0
St Vincent's Hospital, Melbourne
Country [1] 1139 0
Australia
Primary sponsor type
Individual
Name
Dr Bradley La Ferlita
Address
Country
Secondary sponsor category [1] 996 0
Hospital
Name [1] 996 0
St Vincent's Hospital, Melbourne
Address [1] 996 0
Country [1] 996 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2460 0
St Vincent's Hospital
Ethics committee address [1] 2460 0
Melbourne, Vic
Ethics committee country [1] 2460 0
Australia
Date submitted for ethics approval [1] 2460 0
Approval date [1] 2460 0
Ethics approval number [1] 2460 0

Summary
Brief summary
To investigate a commonly used anti-nausea drug, tropisetron, and its application to preventing post-cardiopulmonary bypass delirium.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35246 0
Address 35246 0
Country 35246 0
Phone 35246 0
Fax 35246 0
Email 35246 0
Contact person for public queries
Name 10010 0
Dr Bradley La Ferlita
Address 10010 0
c/o Department of Anaesthesia
St Vincent's Hospital
Victoria Pde
Fitzroy VIC 3065
Country 10010 0
Australia
Phone 10010 0
+61 3 92882211
Fax 10010 0
+61 3 92884255
Email 10010 0
bradley.laferlita@svhm.org.au
Contact person for scientific queries
Name 938 0
Dr Bradley La Ferlita
Address 938 0
c/o Department of Anaesthesia
St Vincent's Hospital
Victoria Pde
Fitzroy VIC 3065
Country 938 0
Australia
Phone 938 0
+61 3 92882211
Fax 938 0
+61 3 92884255
Email 938 0
bradley.laferlita@svhm.org.au

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.