Dexamethasone for heart surgery: a pilot study with a novel design

Dexamethasone for Cardiac Surgery trial: a novel 'Standard Practice Preference-Randomised Consent' Design. A PILOT STUDY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002494-19-NL

Enrollment

1400

Registered

2017-07-07

Start date

2017-12-21

Completion date

Unknown

Last updated

2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory response to cardiac surgery

Interventions

Trade Name: Dexamethasone Product Name: Dexamethasone Product Code: H02AB02 Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients =65 years) no F.1.3.1 Number of subjects for this age range 700

Exclusion criteria

Exclusion criteria: Patients not meeting the inclusion criteria; Children <18 years

Design outcomes

Primary

Measure	Time frame
Main Objective: The Primary Objective of this pilot study is to demonstrate feasibility of SPP-RC trial design, with respect to: 1. Recruitment and consent rates, clinician support, low crossover rate 2. Capacity to collect >95% complete perioperative and outcome data 3. Capacity to obtain sample data for DAH30, complications (MI, stroke, death), duration of mechanical ventilation, and postoperative troponin (myocardial injury) levels;Secondary Objective: Not applicable for this pilot study;Primary end point(s): The main endpoint for this pilot study is feasibility of the study design. The main parameters to be studied are recruitment and consent rates, clinician support, low crossover rate, capacity to collect >95% complete perioperative and outcome data, and the capacity to obtain sample data for DAH30, complications (MI, stroke, death), duration of mechanical ventilation, and postoperative troponin (myocardial injury) levels.;Timepoint(s) of evaluation of this end point: First 30 days after surgery	—

Measure

Time frame

Main Objective: The Primary Objective of this pilot study is to demonstrate feasibility of SPP-RC trial design, with respect to: 1. Recruitment and consent rates, clinician support, low crossover rate 2. Capacity to collect >95% complete perioperative and outcome data 3. Capacity to obtain sample data for DAH30, complications (MI, stroke, death), duration of mechanical ventilation, and postoperative troponin (myocardial injury) levels;Secondary Objective: Not applicable for this pilot study;Primary end point(s): The main endpoint for this pilot study is feasibility of the study design. The main parameters to be studied are recruitment and consent rates, clinician support, low crossover rate, capacity to collect >95% complete perioperative and outcome data, and the capacity to obtain sample data for DAH30, complications (MI, stroke, death), duration of mechanical ventilation, and postoperative troponin (myocardial injury) levels.;Timepoint(s) of evaluation of this end point: First 30 days after surgery

—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Netherlands

Contacts

Public ContactStudy Coordinator

UMC Utrecht

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026