NCT06697405

Impact of Cardiopulmonary Bypass Time on Gastrointestinal Complications

Incidence, Risk Factors, and Outcomes of Gastrointestinal Complications in Patients Undergoing Heart Valve Replacement With Cardiopulmonary Bypass

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,444 (actual)
• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This retrospective study investigates the relationship between cardiopulmonary bypass (CPB) duration and the incidence of gastrointestinal complications (GICs) in patients undergoing heart valve replacement. Patients will be grouped into a normal CPB group (CPB \<120 minutes) and a prolonged CPB group (CPB ≥120 minutes). The study aims to determine whether prolonged CPB time is associated with a higher risk of GICs and to evaluate the outcomes and recovery process for patients who develop GICs postoperatively.

Detailed description

Heart valve replacement with CPB carries a risk of GICs due to potential ischemia-reperfusion injury to the gastrointestinal tract. GICs in the postoperative period can lead to increased morbidity and prolong recovery. Prolonged CPB time may serve as a predictive factor for the development of GICs following heart valve replacement. This study will utilize established diagnostic criteria to define GICs, which include clinical symptoms, laboratory tests, and imaging as necessary, based on standards from critical care and gastrointestinal surgery guidelines. By understanding this correlation, the study aims to reduce the incidence and severity of postoperative GICs and improve surgical outcomes.

Conditions

• Valvular Disease

Interventions

Type	Name	Description
OTHER	Prolonged ≥ 120 minutes	No intervention, regular therapy

Timeline

• Start date: 2024-12-24
• Primary completion: 2025-12-25
• Completion: 2025-12-25
• First posted: 2024-11-20
• Last updated: 2025-12-31

Locations

1 site across 1 country: China