Neuroaxial Prophylaxis for CABG | NCT04244435

Studies
Neuroaxial Prophylaxis for CABG

NCT04244435

Sponsor

Volgograd State Medical University

Status

Unknown status

Last Update Posted

Sep 21, 2021Actual

Enrollment

300Estimated

Phase

Early Phase 1

Conditions

Coronary Artery Occlusion

Interventions

CABG
thoracic epidural analgesia
analgesia of opioids

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2020Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Jan 31, 2022Estimated

First Submitted Date

Jan 20, 2020

First Submission Date that Met QC Criteria

Jan 27, 2020

First Posted Date

Jan 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2021

Last Update Posted Date

Sep 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mikhail I Turovets, MD, professor, Volgograd State Medical UniversityPrincipal Investigator

Lead Sponsor

Volgograd State Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thoracic epidural analgesia	Experimental	CABG and thoracic epidural analgesia will be used for perioperative analgesia postoperative period	Procedure: CABG Drug: thoracic epidural analgesia
Opioids	Active Comparator	CABG and opioids will be used for perioperative analgesia	Procedure: CABG Drug: analgesia of opioids
CABG	Active Comparator	coronary artery bypass grafting with and without cardiopulmonary bypass	Procedure: CABG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CABG	Procedure	coronary artery bypass grafting with and without cardiopulmonary bypass	CABG Opioids Thoracic epidural analgesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hospital mortality		1 year
Hospitalization duration		1 year
Duration of treatment in the intensive care unit		up to 1 year

Secondary Outcomes

Measure	Description	Time Frame
Complications		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

coronary artery bypass grafting

Exclusion Criteria:

Absolute contraindications for the use of thoracic epidural analgesia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital №1 of Volgograd State Medical University		Volgograd		400079	Russia

Condition Browse Module

MeSH Terms

ID	Term
D054059	Coronary Occlusion

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013662	Tea

Ancestor Terms

ID	Term
D028321	Plant Preparations
D001688	Biological Products
D045424	Complex Mixtures
D001628	Beverages

Browse Leaves

Not provided

Browse Branches

Not provided