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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03002259




Registration number
NCT03002259
Ethics application status
Date submitted
21/12/2016
Date registered
23/12/2016
Date last updated
20/03/2019

Titles & IDs
Public title
Dexamethasone for Cardiac Surgery-II Trial
Scientific title
Evaluation of Dexamethasone in Cardiac Surgery Using a Novel Trial Design
Secondary ID [1] 0 0
69
Universal Trial Number (UTN)
Trial acronym
DECS-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Response 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
days at home up to 30 days after surgery - Home is defined as a person's usual abode or that of a close relative, excluding any nursing facility (rehabilitation center or nursing home).
Timepoint [1] 0 0
30 days from Start of Surgery
Secondary outcome [1] 0 0
respiratory failure - Uninterrupted postoperative mechanical ventilation for more than 48 hours from admission to ICU
Timepoint [1] 0 0
30 days from Start of Surgery
Secondary outcome [2] 0 0
Infection - Surgical site infection, pneumonia, or documented positive microbial culture from any site (including blood).
Timepoint [2] 0 0
30 days from Start of Surgery
Secondary outcome [3] 0 0
Myocardial Infarction - Postoperative myocardial infarction will be defined according to the third universal definition
Timepoint [3] 0 0
30 days from Start of Surgery
Secondary outcome [4] 0 0
Stroke - A new neurological deficit lasting more than 24 hours or leading to earlier death, and confirmed by medical imaging.
Timepoint [4] 0 0
30 days from Start of Surgery
Secondary outcome [5] 0 0
Peak blood glucose - The highest blood glucose measured in this same period
Timepoint [5] 0 0
30 days from Start of Surgery
Secondary outcome [6] 0 0
Length of stay - Time from postoperative ICU admission to ICU discharge (hours) and hospital discharge (days).
Timepoint [6] 0 0
30 days from Start of Surgery
Secondary outcome [7] 0 0
Quick SOFA score - Tachypnoea, altered mentation and/or hypotension
Timepoint [7] 0 0
Each evening on days 1-3 after surgery

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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
UMC Utrecht
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03002259
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul S Myles, MBBS, MD
Address 0 0
Alfred Hospital, Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul S Myles, MBBS, MD
Address 0 0
Country 0 0
Phone 0 0
+61390762000
Fax 0 0
Email 0 0
p.myles@alfred.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03002259