Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12606000086561
Ethics application status
Approved
Date submitted
25/02/2006
Date registered
1/03/2006
Date last updated
1/03/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Dexmedetomidine on MAAS in severely agitated, mechanicaaly ventilated, critically ill patients
Scientific title
The effect of Dexmedetomidine on MAAS in severely agitated, mechanicaaly ventilated, critically ill patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agitation in mechanically ventilated ICU patients. 1050 0
Condition category
Condition code
Other 1130 1130 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who meet the inclusion creteria were given a continuous intravenous infusion of Dexmedetomidine (0.4 - 1.0mic/kg/hr) up to 7 days.
Intervention code [1] 920 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1515 0
Motor Activity Assessment Score (MASS)
Timepoint [1] 1515 0
At 6 and 12 hours
Secondary outcome [1] 2729 0
1. Length of mechanical ventilation in ICU
Timepoint [1] 2729 0
Secondary outcome [2] 2730 0
2. Ventilation time pre Dexmedetomidine in ICU
Timepoint [2] 2730 0
Secondary outcome [3] 2731 0
3. Ventilation time post Dexmedetomidine in ICU
Timepoint [3] 2731 0
Secondary outcome [4] 2732 0
4. Number of patients extubated whilst on Dexmedetomidine in ICU
Timepoint [4] 2732 0
Secondary outcome [5] 2733 0
5. Number of tracheostomy in ICU
Timepoint [5] 2733 0
Secondary outcome [6] 2734 0
6. Number of self extubation in ICU
Timepoint [6] 2734 0
Secondary outcome [7] 2735 0
7. Number of reintubations in ICU
Timepoint [7] 2735 0
Secondary outcome [8] 2736 0
8. Use of other sedatives in ICU
Timepoint [8] 2736 0
Secondary outcome [9] 2737 0
9. Use of vasopressor and vasodilator infusions in ICU
Timepoint [9] 2737 0

Eligibility
Key inclusion criteria
1.Patient requiring invasive ventilation for longer than 24 hours. 2.Receiving narcotics and /or sedatives for longer than 24 hours. 3.Development of clinical agitation and/or delirium upon weaning narcotics and/or sedatives on commencement of weaning from mechanical ventilation 4.Informed consent signed by person responsible within 24 hours of enrolment. 5. Have failed conventional sedative therapy as assessed by the treating intensivist.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Allergy to Dexmedetomidine.2.Patients who are or likely to be pregnant or lactating.3.Patients receiving other long term alpha 2 agonists.4. Involvement in a sedation study within the last 30 days.5. Known opiate or benzodiazepines dependence, treatment for chronic pain or recent detoxification therapy within the last 6 months. 6. Patients on anti-psychotic drugs 7. Known dementia, Parkinsonism or epilepsy.8. Patients with recent cerebro-vascular surgery or traumatic brain injury.9. Any evidence of critical illness polyneuropathy.10. Recent surgery involving free flap.11. Haemodynamically unstable patients with Systolic blood pressure < 90 mmHg and or Heart rate < 55 / min.12. Patients on CVVHD.13. Patients with hepatic encephalopathy within 14 days.14. Patients with a recent drug overdose or CO poisoning.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2004
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)

Funding & Sponsors
Funding source category [1] 1232 0
Charities/Societies/Foundations
Name [1] 1232 0
Intensive care research fund
Country [1] 1232 0
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Country
Australia
Secondary sponsor category [1] 1089 0
None
Name [1] 1089 0
Nil
Address [1] 1089 0
Country [1] 1089 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35380 0
Address 35380 0
Country 35380 0
Phone 35380 0
Fax 35380 0
Email 35380 0
Contact person for public queries
Name 10109 0
Naomi Hammond
Address 10109 0
Intensive Care Unit
Prince of Wales Hospital
Level 1
Dickinson Building
Barker St
Randwick NSW 2031
Country 10109 0
Australia
Phone 10109 0
+61 2 93824720
Fax 10109 0
Email 10109 0
[email protected]
Contact person for scientific queries
Name 1037 0
Dr Yahya Shehabi
Address 1037 0
Intensive Care Unit
Prince of Wales Hospital
Level 1
Dickinson Building
Barker St
Randwick NSW 2031
Country 1037 0
Australia
Phone 1037 0
+61 2 93824721
Fax 1037 0
Email 1037 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.