NCT03002259

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,956

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

4.4 years

First QC Date

December 21, 2016

Last Update Submit

January 9, 2023

Conditions

Inflammatory Response

Keywords

cardiac surgery

Outcome Measures

Primary Outcomes (1)

  • 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).

    30 days from Start of Surgery

Secondary Outcomes (7)

  • respiratory failure

    30 days from Start of Surgery

  • Infection

    30 days from Start of Surgery

  • Myocardial Infarction

    30 days from Start of Surgery

  • Stroke

    30 days from Start of Surgery

  • Peak blood glucose

    30 days from Start of Surgery

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

No placebo required

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone, 1 mg/kg (maximal dose 100 mg), single dose administration before cardiopulmonary bypass

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

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.

Dexamethasone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females, age 18 to 75 years undergoing elective cardiac surgery with cardiopulmonary bypass
  • EuroScore-II estimated risk of 1.5% or higher

You may not qualify if:

  • Poor language (English or Dutch) comprehension
  • Type I diabetes
  • Endocarditis or other evidence of sepsis
  • Preoperative steroid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Related Publications (2)

  • Abbasciano RG, Olivieri GM, Chubsey R, Gatta F, Tyson N, Easwarakumar K, Fudulu DP, Marsico R, Kofler M, Elshafie G, Lai F, Loubani M, Kendall S, Zakkar M, Murphy GJ. Prophylactic corticosteroids for cardiopulmonary bypass in adult cardiac surgery. Cochrane Database Syst Rev. 2024 Mar 20;3(3):CD005566. doi: 10.1002/14651858.CD005566.pub4.

    PMID: 38506343DERIVED

  • 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.

    PMID: 30081275DERIVED

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Paul S Myles, MBBS, MD

    Alfred Hospital, Monash University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

December 23, 2016

Study Start

September 1, 2018

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

January 11, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)