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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03002259
Registration number
NCT03002259
Ethics application status
Date submitted
21/12/2016
Date registered
23/12/2016
Titles & IDs
Public title
Dexamethasone for Cardiac Surgery-II Trial
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Scientific title
Evaluation of Dexamethasone in Cardiac Surgery Using a Novel Trial Design
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Secondary ID [1]
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69
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Universal Trial Number (UTN)
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Trial acronym
DECS-II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Inflammatory Response
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dexamethasone
No intervention: Control - No placebo required
Active comparator: Dexamethasone - Dexamethasone, 1 mg/kg (maximal dose 100 mg), single dose administration before cardiopulmonary bypass
Treatment: Drugs: Dexamethasone
Dexamethasone administered as a single IV injection after induction of anaesthesia, but before initiation of CPB. Prepare as a 20 mg/mL dexamethasone solution, made up with 0.9% saline to 10 ml.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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days at home up to 30 days after surgery
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Assessment method [1]
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Home is defined as a person's usual abode or that of a close relative, excluding any nursing facility (rehabilitation center or nursing home).
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Timepoint [1]
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30 days from Start of Surgery
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Secondary outcome [1]
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respiratory failure
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Assessment method [1]
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Uninterrupted postoperative mechanical ventilation for more than 48 hours from admission to ICU
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Timepoint [1]
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30 days from Start of Surgery
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Secondary outcome [2]
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Infection
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Assessment method [2]
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Surgical site infection, pneumonia, or documented positive microbial culture from any site (including blood).
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Timepoint [2]
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30 days from Start of Surgery
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Secondary outcome [3]
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Myocardial Infarction
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Assessment method [3]
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Postoperative myocardial infarction will be defined according to the third universal definition
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Timepoint [3]
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30 days from Start of Surgery
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Secondary outcome [4]
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Stroke
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Assessment method [4]
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A new neurological deficit lasting more than 24 hours or leading to earlier death, and confirmed by medical imaging.
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Timepoint [4]
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30 days from Start of Surgery
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Secondary outcome [5]
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Peak blood glucose
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Assessment method [5]
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The highest blood glucose measured in this same period
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Timepoint [5]
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30 days from Start of Surgery
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Secondary outcome [6]
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Length of stay
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Assessment method [6]
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Time from postoperative ICU admission to ICU discharge (hours) and hospital discharge (days).
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Timepoint [6]
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30 days from Start of Surgery
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Secondary outcome [7]
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Quick SOFA score
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Assessment method [7]
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Tachypnoea, altered mentation and/or hypotension
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Timepoint [7]
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Each evening on days 1-3 after surgery
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Eligibility
Key inclusion criteria
1. Males and females, age 18 to 75 years undergoing elective cardiac surgery with cardiopulmonary bypass
2. EuroScore-II estimated risk of 1.5% or higher
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Poor language (English or Dutch) comprehension
2. Type I diabetes
3. Endocarditis or other evidence of sepsis
4. Preoperative steroid therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/01/2023
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Actual
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Sample size
Target
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Accrual to date
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Final
1956
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Health - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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UMC Utrecht
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Background. Numerous studies have investigated high-dose corticosteroids in cardiac surgery, but with mixed results leading to ongoing variations in practice around the world. The Dexamethasone for Cardiac Surgery-II Trial (DECS-II) is a study comparing high-dose dexamethasone with placebo in patients undergoing cardiac surgery. Methods. We discuss the rationale for conducting DECS-II, a 2800-patient, pragmatic, multicenter, assessor-blinded, randomized trial in cardiac surgery, and the features of the DECS-II study design (objectives, end points, target population, balanced clusters based on practice preference with post-randomization consent, treatments, patient follow-up and analysis). Conclusions. The DECS-II Trial will use a novel, efficient trial design to evaluate whether high-dose dexamethasone has a patient-centered benefit of enhancing recovery and increasing the number of days at home after cardiac surgery.
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Trial website
https://clinicaltrials.gov/study/NCT03002259
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Trial related presentations / publications
Myles PS, Dieleman JM, Forbes A, Heritier S, Smith JA. Dexamethasone for Cardiac Surgery trial (DECS-II): Rationale and a novel, practice preference-randomized consent design. Am Heart J. 2018 Oct;204:52-57. doi: 10.1016/j.ahj.2018.06.008. Epub 2018 Jun 21.
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Public notes
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Contacts
Principal investigator
Name
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Paul S Myles, MBBS, MD
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Address
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Alfred Hospital, Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03002259