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

Coronary Artery Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05487508
• Other study ID #: LBB.01.01/VII/239/KEP.050/2018
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: August 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Inflammatory Response

Intervention

Drug:
• Dexamethasone
Administration of intraoperative 1 mg/kg body weight dexamethasone
• Normal saline
Placebo (NaCl 0.9%)

Locations

Country	Name	City	State
Indonesia	National Cardiovascular Center Harapan Kita	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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)
Primary	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	Inflammatory reactions	Measurement of interleukin (IL)-6, C-reactive protein (CRP), and procalcitonin	18 to 24 hours post surgery