On-pump Versus Off-pump Coronary Artery Bypass Grafting , Short Term Outcomes , Sohag Experience

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06069986
Collaborator
(none)
120
1
2
12
10

Study Details

Study Description

Brief Summary

Coronary artery disease (CAD) and its sequlae, such as myocardial infarction, arrhythmia and heart failure, are among the leading causes of death around the world . the durable role of coronary artery bypass grafting (CABG) in the treatment of CAD has long been shown.

Coronary artery bypass grafting (CABG) is a commonly performed surgical procedure for patients with coronary artery disease (CAD), CABG can be performed using either the on-pump or off-pump technique, each with its own advantages and limitations.

On-pump CABG involves the use of CPB which as agold standard for surgical coronary revascularization has led toexcellent results in mortality and complications. On-pump CABG allows the surgeon to temporarily stop the heart and provide perfusion and oxygenation to the body. This technique provides a bloodless and motionless operative field, allowing for precise graft anastomosis. However, the use of CPB is associated with deleterious effects as systemic inflammatory response, hemodilution, and organ dysfunction as dysrhythmia and neurocognitive problems. These factors may adversely affect patients lives specially those with impaired EF, who already have compromised cardiovascular function.

Another technique for CABG is on-pump beating heart CABG (ONBH-CABG) surgery that is relatively novel hybrid approach to coronary artery grafting which aims to stabilize hemodynamic parameters during the operative period. This has specific benefits such as reduced preload alongside the afterload which decreases the oxygen demand of the myocardial tissue

Condition or Disease Intervention/Treatment Phase
  • Procedure: coronary artery bypass graft CABG
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
On-pump Versus Off-pump Coronary Artery Bypass Grafting , Short Term Outcomes , Sohag Experience
Actual Study Start Date :
Jul 10, 2023
Anticipated Primary Completion Date :
Jul 10, 2024
Anticipated Study Completion Date :
Jul 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: on pump CABG

using cardiopulmonary bypass

Procedure: coronary artery bypass graft CABG
comparison between onpump and off pump CABG

Active Comparator: off pump CABG

without cardiopulmonary bypass

Procedure: coronary artery bypass graft CABG
comparison between onpump and off pump CABG

Outcome Measures

Primary Outcome Measures

  1. comparison to declare the rate of morbidity and mortality using both techniques on pump and off pump in CABG and which is better in short term outcomes [1 year]

    which is better in morbidity and mortality, on pump or off pump CABG specially in patients with low ejection fraction (less than 40%)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • fair and impaired EF
Exclusion Criteria:
  • malignancy

  • COPD

  • renal failure on dialysis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag university Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ziad Essam Ahmed, assistant lecturer cardithoracic surgery sohag university, Sohag University
ClinicalTrials.gov Identifier:
NCT06069986
Other Study ID Numbers:
  • Soh-Med-23-09-1MD
First Posted:
Oct 6, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2023