Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001171606
Ethics application status
Approved
Date submitted
18/10/2023
Date registered
13/11/2023
Date last updated
20/02/2024
Date data sharing statement initially provided
13/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
DExmedetomidine in Cardiac surgical Intraoperative Drug Evaluation
Scientific title
Dexmedetomidine in Cardiac surgical intraoperative drug evaluation (DECIDE): a triple-blind, placebo-controlled, randomised trial evaluating whether dexmedetomidine improves: cognition, days alive and coma free in patients aged 65 years or older.
Secondary ID [1] 310636 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DECIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 331519 0
Condition category
Condition code
Anaesthesiology 328252 328252 0 0
Anaesthetics
Surgery 328253 328253 0 0
Other surgery
Cardiovascular 328649 328649 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dexmedetomidine, 0.7 mcg/kg/h intraoperatively and 0.1-1 mcg/kg/h until extubation, administered intravenously.
Intervention code [1] 327037 0
Prevention
Comparator / control treatment
An equivalent dose of saline, intraoperatively and until extubation, administered intravenously
Control group
Placebo

Outcomes
Primary outcome [1] 336118 0
Days alive and free of delirium and coma in the first 14 days post-operatively
Timepoint [1] 336118 0
14 days post-operative
Secondary outcome [1] 426887 0
Number of Days Alive and at Home in the first 30 days postoperatively
Timepoint [1] 426887 0
30 days post-operative
Secondary outcome [2] 427847 0
Incidence of stage 2 or 3 acute kidney injury in the first 14 days postoperatively
Timepoint [2] 427847 0
Daily for 14 days post-operative
Secondary outcome [3] 427848 0
Number of Ventilator-free days in first 14 days postoperatively
Timepoint [3] 427848 0
14 days postoperative
Secondary outcome [4] 427849 0
Change in cognitive status
Timepoint [4] 427849 0
Days 30, 90 and 365 post-operative
Secondary outcome [5] 427850 0
Mortality
Timepoint [5] 427850 0
90 days postoperative

Eligibility
Key inclusion criteria
1. Adults undergoing cardiac surgery with cardiopulmonary bypass
2. Age 65 years and older
3. Sufficient English language to complete the cognitive testing in the opinion of the research team
4. Willing and able to comply with all study requirements, including treatment, timing, and assessments.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Dementia (pre-existing confirmed clinical diagnosis)
2. Known allergy to Dexmedetomidine (DEX)
3. Second or third-degree heart block
4. Heart rate less than 55 unless on concomitant beta blockade
5. Renal dialysis within 30 days of surgery
6. Life expectancy of less than 30 days regardless of surgery
7. Preoperative mechanical support other than intra-aortic balloon pump
8. Salvage surgery requiring cardiopulmonary resuscitation
9. Child-Pugh class C liver Cirrhosis
10. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the study procedures.
11. Hearing loss, or medical or psychiatric condition that could preclude the ability of the patient to comply with study procedures.
12. Prior enrolment in DECIDE trial in prior 12 months.

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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
1/03/2027
Actual
Date of last data collection
Anticipated
1/03/2028
Actual
Sample size
Target
1100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 25793 0
The Alfred - Melbourne
Recruitment hospital [2] 25794 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 25795 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [4] 25796 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 25797 0
Westmead Hospital - Westmead
Recruitment hospital [6] 25798 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 41621 0
2031 - Randwick
Recruitment postcode(s) [2] 41620 0
2050 - Camperdown
Recruitment postcode(s) [3] 41622 0
2145 - Westmead
Recruitment postcode(s) [4] 41619 0
3004 - Melbourne
Recruitment postcode(s) [5] 41623 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 314853 0
Government body
Name [1] 314853 0
National Health and Medical Research Council (NHMRC)
Country [1] 314853 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
NHMRC Clinical Trials Centre, University of Sydney, Medical Foundation Building 92-94 Parramatta Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 317040 0
None
Name [1] 317040 0
Address [1] 317040 0
Country [1] 317040 0
Other collaborator category [1] 282844 0
Other Collaborative groups
Name [1] 282844 0
ANZCA Clinical TrialsNetwork
Address [1] 282844 0
ANZCA House, 630 St Kilda Road Melbourne, Victoria 3004 Australia
Country [1] 282844 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313852 0
Sydney Local Health District (RPAH Zone)
Ethics committee address [1] 313852 0
Research Ethics and Governance Office Royal Prince Alfred Hospital Camperdown NSW 2050
Ethics committee country [1] 313852 0
Australia
Date submitted for ethics approval [1] 313852 0
13/10/2023
Approval date [1] 313852 0
05/12/2023
Ethics approval number [1] 313852 0

Summary
Brief summary
Delirium (confusion) is a common complication of cardiac surgery. Dexmedetomidine, a routinely used sedative, has been shown to reduce delirium in different populations. This study aims to test if dexmedetomidine can reduce delirium after surgery in patients undergoing cardiac surgery aged 65 years or older. The aim of the study is to see whether a medication called dexmedetomidine (a routinely used sedative) impacts delirium after surgery. We hypothesize that dexmedetomidine will reduce delirium after surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129558 0
Prof Robert Sanders
Address 129558 0
NHMRC Clinical Trials Centre Level 6 COB Lifehouse 119-1443 Missenden Rd Camperdown NSW 2050
Country 129558 0
Australia
Phone 129558 0
+61 02 9515 8507
Fax 129558 0
Email 129558 0
robert.sanders@sydney.edu.au
Contact person for public queries
Name 129559 0
Ms Besa Beqaj
Address 129559 0
NHMRC Clinical Trials Centre Level 6 COB Lifehouse 119-1443 Missenden Rd Camperdown NSW 2050
Country 129559 0
Australia
Phone 129559 0
+61 02 9562 5000
Fax 129559 0
Email 129559 0
decide.study@sydney.edu.au
Contact person for scientific queries
Name 129560 0
Prof Robert Sanders
Address 129560 0
NHMRC Clinical Trials Centre Level 6 COB Lifehouse 119-1443 Missenden Rd Camperdown NSW 2050
Country 129560 0
Australia
Phone 129560 0
+61 2 9562 5000
Fax 129560 0
Email 129560 0
robert.sanders@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.