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

NCT ID: NCT06873620

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 348 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-23
• Study Completion Date: 2025-10-15

Brief 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

CABG; Cardiac Anesthesia; Cardiac Surgery Prognosis; Bypass Complication; On-pump Valve Surgery or CABG; Anesthesia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

on-pomp CABG

All eligible patients undergoing on-pump-assisted CABG surgery will be included in this group.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients undergoing open heart surgery
• Undergo on pump surgery

Exclusion Criteria

• Patients undergoing emergency open heart surgery Patients undergoing open heart surgery on a beating heart

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahmet Yuksek

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ahmet Yuksek

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mehmet Yilmaz, Associate Proffessor

Role: PRINCIPAL_INVESTIGATOR

Kocaeli City Hospital

Locations

Kocaeli City Hospital

Kocaeli, Izmit, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

PMID: 31723349 (View on PubMed)

Moh'd AF, Al-Odwan HT, Altarabsheh S, Makahleh ZM, Khasawneh MA. Predictors of aortic clamp time duration and intensive care unit length of stay in elective adult cardiac surgery. Egypt Heart J. 2021 Oct 22;73(1):92. doi: 10.1186/s43044-021-00195-0.

Reference Type: BACKGROUND

PMID: 34677684 (View on PubMed)

Parmana IMA, Boom CE, Rachmadi L, Hanafy DA, Widyastuti Y, Mansyur M, Siswanto BB. Correlation Between Cardiac Index, Plasma Troponin I, Myocardial Histopathology, CPB and AoX Duration in Glutamine versus No Glutamine Administered Patients with Low Ejection Fraction Undergoing Elective On-Pump CABG Surgery: Secondary Analysis of an RCT. Vasc Health Risk Manag. 2023 Feb 28;19:93-101. doi: 10.2147/VHRM.S399925. eCollection 2023.

Reference Type: BACKGROUND

PMID: 36880009 (View on PubMed)

Hadipourzadeh F, Rastravan R, Totonchi Z, Heydarpur E, Faritous Z. Evaluating the relationship between lactate levels during coronary artery bypass graft surgery and postoperative renal dysfunction. J Cardiovasc Thorac Res. 2024;16(2):129-134. doi: 10.34172/jcvtr.33051. Epub 2024 Jun 25.

Reference Type: BACKGROUND

PMID: 39253341 (View on PubMed)

Other Identifiers

KSH-2024-23

Identifier Type: -

Identifier Source: org_study_id