Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000892819
Ethics application status
Approved
Date submitted
12/08/2012
Date registered
22/08/2012
Date last updated
22/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dexmedetomidine pharmacodynamics and population pharmacokinetics in elderly intensive care unit (ICU) patients
Scientific title
Dexmedetomidine pharmacodynamics and population pharmacokinetics in elderly Intensive Care Unit (ICU) patients aged 65 and above.
Secondary ID [1] 280634 0
None
Universal Trial Number (UTN)
U1111-1126-3682
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive Care patients aged 65 and more 279378 0
Condition category
Condition code
Anaesthesiology 285562 285562 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible patients will be administered 0.2 to 0.5 mcg/kg/hr intravenous dexmedetomidine to achieve RASS score of 0 to -2. Pharmacodynamic parameters monitored are the RASS score, heart rate, blood pressure, respiratory rate, temperature. Sparse blood samples will be taken to measure serum dexmedetomidine levels, where the population pharmacokinetics will be studied.

The pharmacodynamic parameters will be continuous for 48 hours, and the blood sampling will occur six times over 48 hours.
Intervention code [1] 285031 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287734 0
Optimal dose of dexmedetomidine in elderly patients in a Malaysian Intensive Care Unit will be assessed clinically with the RASS (Richmond Agitation Sedation Scale), mean arterial pressure and heart rate.
Timepoint [1] 287734 0
After completion of data collection
Secondary outcome [1] 298736 0
Population pharmacokinetics will be determined with serum samples taken at different intervals during dexmedetomidine infusion, and analysed via chromatography. Data collected will be analysed via NONMEM.
Timepoint [1] 298736 0
After completion of data collection

Eligibility
Key inclusion criteria
Intensive Care Unit (ICU) patients at the University of Malaya Medical Centre (UMMC) requiring invasive ventilation and sedation of at least 48 hours duration
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient or relative refusal
2. Previous adverse reaction to alpha2 agonists
3. Second degree or higher heart blocks
4. Liver failure
5. Kidney failure requiring renal replacement therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
ICU physician in charged of an eligible subject determines the indication of sedation. After ruling out the exclusion criteria, consent is obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4005 0
Malaysia
State/province [1] 4005 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 285798 0
University
Name [1] 285798 0
University of Malaya
Country [1] 285798 0
Malaysia
Primary sponsor type
Individual
Name
Noorjahan Haneem binti Md Hashim
Address
Department of Anaesthesiology,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 284622 0
Individual
Name [1] 284622 0
Lucy Chan
Address [1] 284622 0
Department of Anaesthesiology,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country [1] 284622 0
Malaysia
Secondary sponsor category [2] 284623 0
Individual
Name [2] 284623 0
Gracie Ong Siok Yan
Address [2] 284623 0
Department of Anaesthesiology,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country [2] 284623 0
Malaysia
Other collaborator category [1] 277010 0
Individual
Name [1] 277010 0
Wong Kang Kwong
Address [1] 277010 0
Department of Anaesthesiology,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country [1] 277010 0
Malaysia
Other collaborator category [2] 277011 0
Individual
Name [2] 277011 0
Suresh Venugobal
Address [2] 277011 0
Department of Anaesthesiology,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country [2] 277011 0
Malaysia
Other collaborator category [3] 277012 0
Individual
Name [3] 277012 0
Mohd Shahnaz Hasan
Address [3] 277012 0
Department of Anaesthesiology,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country [3] 277012 0
Malaysia
Other collaborator category [4] 277013 0
Individual
Name [4] 277013 0
Vineya Rai Hakumat Rai
Address [4] 277013 0
Department of Anaesthesiology,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country [4] 277013 0
Malaysia
Other collaborator category [5] 277014 0
Individual
Name [5] 277014 0
Mustafa Ali Mohd
Address [5] 277014 0
SUCXeS Laboratory,
Department of Pharmacology
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country [5] 277014 0
Malaysia
Other collaborator category [6] 277015 0
Individual
Name [6] 277015 0
Lee Toong Chow
Address [6] 277015 0
Dean's Office,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country [6] 277015 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287814 0
University of Malaya Medical Centre Ethics Committee
Ethics committee address [1] 287814 0
Ethics committee country [1] 287814 0
Malaysia
Date submitted for ethics approval [1] 287814 0
08/06/2011
Approval date [1] 287814 0
01/07/2011
Ethics approval number [1] 287814 0
1/07/0859

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

Contacts
Principal investigator
Name 33522 0
Address 33522 0
Country 33522 0
Phone 33522 0
Fax 33522 0
Email 33522 0
Contact person for public queries
Name 16769 0
Noorjahan Haneem binti Md Hashim
Address 16769 0
Department of Anaesthesiology,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country 16769 0
Malaysia
Phone 16769 0
+60379492052
Fax 16769 0
+60379556705
Email 16769 0
[email protected]
Contact person for scientific queries
Name 7697 0
Noorjahan Haneem binti Md Hashim
Address 7697 0
Department of Anaesthesiology,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country 7697 0
Malaysia
Phone 7697 0
+60379492052
Fax 7697 0
+0379556705
Email 7697 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.