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Efficacy of Dexamethasone to Improve Clinical Outcomes in Coronary Artery Bypass Patients

NCT05487508 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-08-04

No results posted yet for this study

Summary

This is a single-center, double-blind, randomized controlled clinical trial comparing four groups: placebo conventional coronary artery bypass graft (CCABG) group, dexamethasone CCABG group, placebo off-pump coronary artery bypass (OPCAB) group, and dexamethasone OPCAB group. The primary outcomes of this study is comprised of presence of arrhythmia, major adverse cardiac events (MACE), myocardial infarction, stroke, renal failure, respiratory failure, inflammation, and death. These primary outcomes were assessed during the surgery, 18 hours post surgery, every day during the hospital stay, 14 days and 30 days post surgery.

Conditions

Interventions

DRUG

Dexamethasone

Administration of intraoperative 1 mg/kg body weight dexamethasone

DRUG

Normal saline

Placebo (NaCl 0.9%)

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Komite Etik National Cardiovascular Center Harapan Kita · Ethical Committee of National Cardiovascular Center Harapan Kita

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-01-31
Completion
2019-03-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05487508 on ClinicalTrials.gov