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

NCT05487508 | Completed Phase 4

• 1 other identifier: LBB.01.01/VII/239/KEP.050/2018
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease; Inflammatory Response

Keywords

dexamethasone; arrhythmia; atrial fibrillation; ventricular tachycardia; ventricular fibrillation

Outcome Measures

Primary Outcomes (6)

• Presence of arrhythmia as seen on EKG

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

  18 to 24 hours post surgery

• Presence of arrhythmia as seen on EKG

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

  Daily during hospital stay (an average of 7 days)

• Perioperative myocardial infarction as seen on EKG

  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

  18 to 24 hours post surgery

• Perioperative myocardial infarction as seen on EKG

  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

  Daily during hospital stay (an average of 7 days)

• Presence of stroke diagnosed by clinical appearance and CT or MRI

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

  Daily during hospital stay (an average of 7 days)

• Renal failure as measured by serum creatinine

  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

  18 to 24 hours post surgery

Secondary Outcomes (1)

• Inflammatory reactions

  18 to 24 hours post surgery

Study Arms (4)

Dexamethasone CCABG

ACTIVE COMPARATOR

Dexamethasone administered 1 mg per kg body weight (maximum dose 100 mg), given single dose after induction of anesthesia. Surgeon then carried out the conventional coronary artery bypass graft procedure with the use of cardiopulmonary bypass machine.

Drug: Dexamethasone

Placebo CCABG

PLACEBO COMPARATOR

Normal saline (NaCl 0.9%) administered 1 mg per kg body weight (maximum dose 100 mg), given single dose after induction of anesthesia. Surgeon then carried out the conventional coronary artery bypass graft procedure with the use of cardiopulmonary bypass machine.

Drug: Normal saline

Dexamethasone OPCAB

ACTIVE COMPARATOR

Dexamethasone administered 1 mg per kg body weight (maximum dose 100 mg), given single dose after induction of anesthesia. Surgeon then carried out the off-pump coronary artery bypass procedure without the use of cardiopulmonary bypass machine.

Drug: Dexamethasone

Placebo OPCAB

PLACEBO COMPARATOR

Normal saline (NaCl 0.9%) administered 1 mg per kg body weight (maximum dose 100 mg), given single dose after induction of anesthesia. Surgeon then carried out the off-pump coronary artery bypass procedure without the use of cardiopulmonary bypass machine.

Drug: Normal saline

Interventions

Dexamethasone DRUG

Administration of intraoperative 1 mg/kg body weight dexamethasone

Dexamethasone CCABG; Dexamethasone OPCAB

Normal saline DRUG

Placebo (NaCl 0.9%)

Placebo CCABG; Placebo OPCAB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, 11420, Indonesia

Location

Related Publications (1)

• Dieleman JM, Nierich AP, Rosseel PM, van der Maaten JM, Hofland J, Diephuis JC, Schepp RM, Boer C, Moons KG, van Herwerden LA, Tijssen JG, Numan SC, Kalkman CJ, van Dijk D; Dexamethasone for Cardiac Surgery (DECS) Study Group. Intraoperative high-dose dexamethasone for cardiac surgery: a randomized controlled trial. JAMA. 2012 Nov 7;308(17):1761-7. doi: 10.1001/jama.2012.14144.

  PMID: 23117776 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Arrhythmias, Cardiac; Atrial Fibrillation; Tachycardia, Ventricular; Ventricular Fibrillation

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Komite Etik National Cardiovascular Center Harapan Kita

  Ethical Committee of National Cardiovascular Center Harapan Kita

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator) Participants were not aware of the arms/treatment given as they were under general anesthesia during the administration of dexamethasone. Preoperatively, subjects were given explanation of the purpose, methods, benefits, and risks of the procedure including the randomization method. Investigators were kept unaware of the randomization of dexamethasone as they were restricted for assessing the patients' medical record and the patients' identity were coded in the primary database
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A double-blind, single center, multi-arm phase 4 randomized controlled clinical trial was conducted with four intervention arms: placebo CCABG, dexamethasone CCABG, placebo OPCAB, and dexamethasone OPCAB arm. The recruitment of subjects were conducted simultaneously by means of a block randomization.

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 4, 2022
• Study Start: July 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: March 31, 2019
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: September 1st, 2022 for 2 (two) years
• Access Criteria: When needed for systematic review or meta analyses of randomized controlled trials

Locations

ID (1)