Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000640606
Ethics application status
Approved
Date submitted
10/10/2005
Date registered
13/10/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Milrinone for Free Flap Surgery
Scientific title
Milrinone versus placebo infusion intraoperatively to prevent vasospasm during free flap surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Free flap surgery 770 0
Condition category
Condition code
Surgery 846 846 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double-blind, randomised control trial comparing free flap surgery outcomes after intra-operative Milrinone or placebo at 0.25ug/kg/min infusion during anaesthesia with a 25ug/kg bolus over 20 minutes after induction of anaesthesia.
Intervention code [1] 706 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1085 0
Free slap survival at discharge
Timepoint [1] 1085 0
At discharge
Secondary outcome [1] 2019 0
Surgical complications such as thrombosis, heamatoma, dehiscence and the need to return to the operating theatre to resolve these problems during hospitalisation.
Timepoint [1] 2019 0

Eligibility
Key inclusion criteria
Elective patients for free flap surgery.Serious cardiac disease, stenotic or ischaemic cardiac disease and history of ventricular arrhythmias.Previous adverse reaction or allergy to milrinone.Renal impairment Cr > 0.15 mmol/L.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent and patient refusal.

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 envelopes opened at the time of randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computor software PC-Plan was used to generate random allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2002
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] 932 0
Self funded/Unfunded
Name [1] 932 0
Country [1] 932 0
Primary sponsor type
Hospital
Name
Department of Anaesthesia, St Vincent's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 791 0
None
Name [1] 791 0
No secondary sponsor
Address [1] 791 0
Country [1] 791 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35356 0
Address 35356 0
Country 35356 0
Phone 35356 0
Fax 35356 0
Email 35356 0
Contact person for public queries
Name 9895 0
Ms Simone Said
Address 9895 0
Department of Anaesthesia
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy VIC 3065
Country 9895 0
Australia
Phone 9895 0
+61 3 92884245
Fax 9895 0
Email 9895 0
[email protected]
Contact person for scientific queries
Name 823 0
Dr Simon Jones
Address 823 0
Department of Anaesthesia
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy VIC 3065
Country 823 0
Australia
Phone 823 0
+61 3 92884245
Fax 823 0
Email 823 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.