Coronary Artery OcclusionEarly Phase 1NCT04244435
Neuroaxial Prophylaxis for CABG
A Early Phase 1 study testing CABG, thoracic epidural analgesia and analgesia of opioids in people with Coronary Artery Occlusion, run by Volgograd State Medical University at 1 site in Russia.
Trial summary
Investigators plan to study the effect of thoracic epidural analgesia on postoperative parameters (complication rate, duration of hospitalization, mortality, etc.) of coronary artery bypass grafting. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Occlusion
- What is being tested?
- CABG, thoracic epidural analgesia and analgesia of opioids
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- 1 Feb 2020to 31 Jan 2022
- Phase
- Early Phase 1
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary artery bypass grafting
Who cannot join
- Absolute contraindications for the use of thoracic epidural analgesia
Trial locations and contacts
1 site in 1 country.
Russia1 site
Hospital №1 of Volgograd State Medical University
Volgograd, 400079
About this study
Official title: Consequences of Using Thoracic Epidural Analgesia for Coronary Artery Bypass Grafting
Investigators plan to study the effect of thoracic epidural analgesia on postoperative parameters (complication rate, duration of hospitalization, mortality, etc.) of coronary artery bypass grafting.
Read the detailed description
Investigators plan to conduct a comparative analysis of early postoperative complications of coronary artery bypass grafting with and without cardiopulmonary bypass in patients with independent risk factors for the development of postoperative complications (advanced age, diabetes mellitus, chronic kidney disease, obesity, chronic obstructive pulmonary disease) with various types of anesthesiology benefits (general anesthesia and thoracic epidural analgesia versus general anesthesia and opioids). Investigators predict a decrease in the risk of developing cardiac, respiratory, infectious and renal complications, a reduction in the duration of intensive care, inpatient treatment and mortality.
- Conditions
- Coronary Artery Occlusion
- Being tested
- CABG, thoracic epidural analgesia, analgesia of opioids
- Keywords
- coronary artery bypass grafting, prevention of complication, neuroaxial prophylaxis, thoracic epidural analgesia
- Medical subject headings
- Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABGProcedure or surgery
coronary artery bypass grafting with and without cardiopulmonary bypass
thoracic epidural analgesiaDrug
thoracic epidural analgesia at the level of 1-10 thoracic vertebrae (ropivacainum 0,2-0,5% 5-10 ml/h)
analgesia of opioidsDrug
Opioids will be used for perioperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| Thoracic epidural analgesia | Experimental | CABG and thoracic epidural analgesia will be used for perioperative analgesia postoperative period Receives: Procedure: CABG; Drug: thoracic epidural analgesia |
| Opioids | Active comparator | CABG and opioids will be used for perioperative analgesia Receives: Procedure: CABG; Drug: analgesia of opioids |
| CABG | Active comparator | coronary artery bypass grafting with and without cardiopulmonary bypass Receives: Procedure: CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital mortality
Measured: 1 year
Hospitalization duration
Measured: 1 year
Duration of treatment in the intensive care unit
Measured: up to 1 year
Secondary outcomes (1)
Complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Feb 2020
- Primary completion31 Dec 2020
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery OcclusionStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Volgograd State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikhail I Turovets, MD, Volgograd State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244435
- Sponsor's protocol ID
- TEA-CABG
- Status last verified
- Sep 2021
- First submitted
- 20 Jan 2020
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Using Thoracic Epidural Analgesia for Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT04244435
- Acronym / sponsor ID
- TEA-CABG
- Conditions
- Coronary Artery Occlusion
- Keywords
- coronary artery bypass grafting, prevention of complication, neuroaxial prophylaxis, thoracic epidural analgesia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Volgograd State Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 28 Jan 2020 (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.
Investigators plan to study the effect of thoracic epidural analgesia on postoperative parameters (complication rate, duration of hospitalization, mortality, etc.) of coronary artery bypass grafting.
Detailed description
Investigators plan to conduct a comparative analysis of early postoperative complications of coronary artery bypass grafting with and without cardiopulmonary bypass in patients with independent risk factors for the development of postoperative complications (advanced age, diabetes mellitus, chronic kidney disease, obesity, chronic obstructive pulmonary disease) with various types of anesthesiology benefits (general anesthesia and thoracic epidural analgesia versus general anesthesia and opioids). Investigators predict a decrease in the risk of developing cardiac, respiratory, infectious and renal complications, a reduction in the duration of intensive care, inpatient treatment and mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thoracic epidural analgesia | Experimental | Procedure: CABG, Drug: thoracic epidural analgesiaCABG and thoracic epidural analgesia will be used for perioperative analgesia postoperative period |
| Opioids | Active comparator | Procedure: CABG, Drug: analgesia of opioidsCABG and opioids will be used for perioperative analgesia |
| CABG | Active comparator | Procedure: CABGcoronary artery bypass grafting with and without cardiopulmonary bypass |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- coronary artery bypass grafting
Key exclusion criteria (1 listed)
- Absolute contraindications for the use of thoracic epidural analgesia
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 |
|---|---|---|
| CABGcoronary artery bypass grafting with and without cardiopulmonary bypass | Procedure or surgery | CABG, Opioids, Thoracic epidural analgesia |
| thoracic epidural analgesiathoracic epidural analgesia at the level of 1-10 thoracic vertebrae (ropivacainum 0,2-0,5% 5-10 ml/h) | Drug | Thoracic epidural analgesia |
| analgesia of opioidsOpioids will be used for perioperative analgesia | Drug | Opioids |
Primary outcome
hospital mortality
Time frame: 1 year
Hospitalization duration
Time frame: 1 year
Duration of treatment in the intensive care unit
Time frame: up to 1 year
1 secondary outcome
Complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
Related trials for Coronary Artery Occlusion
Not yet recruiting
TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention
Coronary Artery Disease (CAD)
Not yet recruitingObservational study
Relationship Between Frontal QRS-T Angle and Collateral Circulation in Coronary Artery Chronic Total Occlusion
Chronic Total Occlusion (CTO), Frontal QRS-T Angle
RecruitingObservational study
Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter
Coronary Artery Disease
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Not yet recruiting
The CORE Platform Trial
Coronary Revascularization, Coronary Artery Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CABG, thoracic epidural analgesia and analgesia of opioids in people with Coronary Artery Occlusion, run by Volgograd State Medical University at 1 site in Russia.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Sep 2021. 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 Russia. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
hospital mortality (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2021.