Clinical Trials Directory

Trials / Completed

CompletedNCT06873620

Impact of the Cardiopulmonary Bypass and Cross-Clamp Time Ratio on Postoperative Outcomes in Open Heart Surgery: A Prospective Observational Analysis

Status
Completed
Phase
Study type
Observational
Enrollment
348 (actual)
Sponsor
Ahmet Yuksek · Other Government
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

This study aims to investigate the relationship between the ratio of cardiopulmonary bypass (CPB) time to cross-clamp (CC) time and postoperative complications in open heart surgery. While CPB time and CC duration have been linked to complications, no study has explored the specific ratio between CPB time and CC time in relation to postoperative outcomes. This prospective study seeks to fill that gap.

Detailed description

Open heart surgery involves several distinct stages: 1) preparation for cardiopulmonary bypass (CPB), 2) the CPB phase, which includes the cross-clamp (CC) process, and 3) hemostasis and closure. During the CPB phase, the left internal mammary artery (LIMA) and saphenous vein are freed for coronary anastomosis, followed by arterial and venous cannulation. Once cannulation is completed, CPB is initiated. A cross-clamp is placed on the aorta to stop the heart, and cardioplegia solution is administered. Afterward, distal anastomoses are performed, and once completed, the cross-clamp is removed and the heart begins to beat again. The duration the cross-clamp remains in place is referred to as the CC time. In the CPB phase, proximal anastomoses are made on the aorta. After checking for any bleeding, thoracic drains are placed, and the CPB is terminated. Once all controls are in place, the chest is closed, and the patient is transferred to the intensive care unit. The mortality rate for open heart surgery varies between 1% and 5%, depending on the patient's specific characteristics. Postoperative complications such as bleeding revision, acute kidney injury, liver failure, respiratory failure, and heart failure are common. Literature has linked these complications to vascular conditions, CPB time, and the duration of cross-clamp time. However, no studies were found that specifically compare the ratio of CPB time to CC time with postoperative complications. In this study, we aim to prospectively investigate the relationship between the ratio of CPB time to cross-clamp time and postoperative complications in patients undergoing open heart surgery.

Conditions

Timeline

Start date
2024-02-23
Primary completion
2025-10-01
Completion
2025-10-15
First posted
2025-03-12
Last updated
2025-11-24

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06873620. Inclusion in this directory is not an endorsement.