Coronary Artery DiseasePhase 4NCT05487508
Efficacy of Dexamethasone to Improve Clinical Outcomes in Coronary Artery Bypass Patients
A Phase 4 study testing Dexamethasone and Normal saline in people with Coronary Artery Disease and Inflammatory Response, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Inflammatory Response
- What is being tested?
- Dexamethasone and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2018to 31 Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary artery disease patients indicated for elective coronary artery bypass surgery
- Patients aged >18 years old
- Patients who agreed to participate in this study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
National Cardiovascular Center Harapan Kita
Jakarta, DKI Jakarta, 11420
About this study
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
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.
Read the 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).
- Conditions
- Coronary Artery Disease, Inflammatory Response
- Being tested
- Dexamethasone, Normal saline
- Keywords
- dexamethasone, arrhythmia, atrial fibrillation, ventricular tachycardia, ventricular fibrillation
- Medical subject headings
- Coronary Artery Disease, Arrhythmias, Cardiac, Atrial Fibrillation, Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Administration of intraoperative 1 mg/kg body weight dexamethasone
Normal salineDrug
Placebo (NaCl 0.9%)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 18 to 24 hours post surgery
Secondary outcomes (1)
Inflammatory reactions
Measurement of interleukin (IL)-6, C-reactive protein (CRP), and procalcitonin
Measured: 18 to 24 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Jul 2018
- Primary completion31 Jan 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dudy Arman Hanafy, Sp. BTKV (K), MARS, Universitas Indonesia
- Investigators
- Komite Etik National Cardiovascular Center Harapan Kita, Study chair, Ethical Committee of National Cardiovascular Center Harapan Kita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487508
- Sponsor's protocol ID
- LBB.01.01/VII/239/KEP.050/2018
- Status last verified
- Aug 2022
- First submitted
- 27 Jul 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, ethical clearance letter, primary database of the study, as well as the study's analysis plan and the manuscript of the study will be made available on the permission by the principal investigator and ethical committee
Publications
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.
PubMed 23117776
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05487508
- Acronym / sponsor ID
- LBB.01.01/VII/239/KEP.050/2018
- Conditions
- Coronary Artery Disease, Inflammatory Response
- Keywords
- dexamethasone, arrhythmia, atrial fibrillation, ventricular tachycardia, ventricular fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone CCABG | Active comparator | Drug: DexamethasoneDexamethasone 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. |
| Placebo CCABG | Placebo comparator | Drug: Normal salineNormal 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. |
| Dexamethasone OPCAB | Active comparator | Drug: DexamethasoneDexamethasone 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. |
| Placebo OPCAB | Placebo comparator | Drug: Normal salineNormal 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Coronary artery disease patients indicated for elective coronary artery bypass surgery
- Patients aged >18 years old
- Patients who agreed to participate in this study
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAdministration of intraoperative 1 mg/kg body weight dexamethasone | Drug | Dexamethasone CCABG, Dexamethasone OPCAB |
| Normal salinePlacebo (NaCl 0.9%) | Drug | Placebo CCABG, Placebo OPCAB |
Primary outcome
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
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
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
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
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
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
1 secondary outcome
Inflammatory reactions
Time frame: 18 to 24 hours post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Background: PubMed 23117776Dieleman 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.
- Individual participant dataSharing planned: Yes. The study protocol, ethical clearance letter, primary database of the study, as well as the study's analysis plan and the manuscript of the study will be made available on the permission by the principal investigator and ethical committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Komite Etik National Cardiovascular Center Harapan Kita study chair
Ethical Committee of National Cardiovascular Center Harapan Kita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Normal saline in people with Coronary Artery Disease and Inflammatory Response, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of arrhythmia as seen on EKG (time frame: 18 to 24 hours post surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05487508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.