Clinical trial NCT05487508: Efficacy of Dexamethasone to Improve Clinical Outcomes in Coronary Artery Bypass Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Inflammatory Response
Keywords: dexamethasone
arrhythmia
atrial fibrillation
ventricular tachycardia
ventricular fibrillation
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Presence of arrhythmia as seen on EKG
timeFrame: 18 to 24 hours post surgery
measure: Presence of arrhythmia as seen on EKG
timeFrame: Daily during hospital stay (an average of 7 days)
measure: Perioperative myocardial infarction as seen on EKG
timeFrame: 18 to 24 hours post surgery
measure: Perioperative myocardial infarction as seen on EKG
timeFrame: Daily during hospital stay (an average of 7 days)
measure: Presence of stroke diagnosed by clinical appearance and CT or MRI
timeFrame: Daily during hospital stay (an average of 7 days)
measure: Renal failure as measured by serum creatinine
timeFrame: 18 to 24 hours post surgery
Secondary outcomes:
measure: Inflammatory reactions
timeFrame: 18 to 24 hours post surgery
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita
state: DKI Jakarta
Study officials:
affiliation: Ethical Committee of National Cardiovascular Center Harapan Kita
name: Komite Etik National Cardiovascular Center Harapan Kita
role: STUDY_CHAIR
References:
citation: 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.