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NCT Number: NCT05487508

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

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.

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Key information

Conditions

Coronary Artery Disease Arrhythmias, Cardiac Arterial Occlusive Diseases Arteriosclerosis Atrial Fibrillation Cardiac Conduction System Disease Cardiovascular Diseases Coronary Disease Heart Diseases Inflammatory Response Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Vascular Diseases Ventricular Fibrillation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, 11420, Indonesia

About this study

A single center randomized controlled clinical trial was conducted at Harapan Kita National Cardiovascular Center, Jakarta, Indonesia, as the tertiary cardiovascular referral hospital. The RCT was conducted from July 1st, 2018 to March 31st, 2019 (current status: completed). This study assessed the efficacy of intraoperative high dose dexamethasone administration (1 mg/kg BW, maximum dose 100 mg) in reducing inflammatory response and improving clinical outcome in patients undergoing coronary artery bypass surgery. The study groups consist of placebo CCABG, dexamethasone CCABG, placebo OPCAB, and dexamethasone OPCAB. The subjects were adults indicated to undergo elective coronary artery bypass surgery with no evidence of prior inflammation nor allergic reaction to dexamethasone. Both the patients and the principal investigators were blinded for the treatment-control allocation. The patients were purposively selected and were randomly assigned to one of the arms with block randomization. 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. The minimum sample size required for this study was 100 subjects (25 each group).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Coronary artery disease patients indicated for elective coronary artery bypass surgery
  • Patients aged >18 years old
  • Patients who agreed to participate in this study

Exclusion criteria

  • Patients with preoperative systemic inflammation evidenced by high axillary temperature (≥38◦C) and high leukocyte count (≥15.000 ul)
  • Patients with chronic arrhythmia
  • Patients who are indicated to undergo other procedures than coronary artery bypass (i.e. valvular repair, septal repair)
  • Patients with history of severe organ dysfunction (class IV congestive heart failure, renal failure, respiratory arrest, and stroke with sequelae)
  • Patients with history of cardiac surgery
  • Patients who takes routine corticosteroids or immunomodulators
  • Patients who are allergic to corticosteroids

Treatment and study plan

Dexamethasone

Drug

Administration of intraoperative 1 mg/kg body weight dexamethasone

normal saline

Drug

Placebo (NaCl 0.9%)

Primary outcomes

  1. Presence of arrhythmia as seen on EKG

    Time frame: 18 to 24 hours post surgery

    New onset of a postoperative rhythm disorder including atrial fibrillation, ventricular tachycardia, ventricular fibrillation, supraventricular tachycardia, and atrioventricular block

  2. Presence of arrhythmia as seen on EKG

    Time frame: Daily during hospital stay (an average of 7 days)

    New onset of a postoperative rhythm disorder including atrial fibrillation, ventricular tachycardia, ventricular fibrillation, supraventricular tachycardia, and atrioventricular block

  3. Perioperative myocardial infarction as seen on EKG

    Time frame: 18 to 24 hours post surgery

    New Q waves or new left bundle branch block on an electrocardiogram, combined with a biomarker (creatine kinase-MB or troponin) >5 times the upper normal limit

  4. Perioperative myocardial infarction as seen on EKG

    Time frame: Daily during hospital stay (an average of 7 days)

    New Q waves or new left bundle branch block on an electrocardiogram, combined with a biomarker (creatine kinase-MB or troponin) >5 times the upper normal limit

  5. Presence of stroke diagnosed by clinical appearance and CT or MRI

    Time frame: Daily during hospital stay (an average of 7 days)

    A neurologic deficit lasting more than 24 hours with signs of a new ischemic cerebral infarction on computed tomography or magnetic resonance imaging

  6. Renal failure as measured by serum creatinine

    Time frame: 18 to 24 hours post surgery

    Increase in postoperative serum creatinine of at least 3-times the preoperative value, or a serum creatinine level >4mg/dL associated with an acute increase in serum creatinine of at leas 0.5mg/dL

Secondary outcomes

  1. Inflammatory reactions

    Time frame: 18 to 24 hours post surgery

    Measurement of interleukin (IL)-6, C-reactive protein (CRP), and procalcitonin

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Efficacy of Dexamethasone to Reduce Inflammatory Response and Improve Clinical Outcome in Coronary Artery Bypass Patients: A Multi Arm, Double Blind, Single Center, Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 4, 2022
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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