Impact of Cardiopulmonary Bypass Time on Gastrointestinal Complications

Recruiting

• Conditions: Valvular Disease

• Registration Number: NCT06697405
• Lead Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Brief 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.

Study Timeline

• Study First Submitted: 2024-11-16
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-20
• Status Verified: 2024-12
• Study Start: 2024-12-24
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

• Patients undergoing heart valve replacement with CPB
• Age ≥ 18 years and ≤ 75 years

Exclusion Criteria

• Have received major gastrointestinal surgery within 5 years.
• History of severe infection (e.g., pneumonia, urinary tract infection) requiring hospitalization within 1 month prior to surgery.
• Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis.
• Acute gastroenteritis.
• Clostridium difficile or Helicobacter pylori infection.
• Chronic constipation.
• Peptic ulcer.
• Polyps in the stomach or intestines.
• Gastrointestinal neoplasms.
• Abdominal hernia.
• Irritable bowel syndrome.
• Acute or chronic cholecystitis, hepatitis.
• Patients who died intraoperatively or within 24 hours postoperatively.
• Patients with digestive system tumors.
• Pregnancy or breastfeeding could affect postoperative medication use and study observations.
• Involvement in other studies that may interfere with the objective results of this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The acute gastrointestinal injury (AGI) score	1 month	The AGI score of the patient within the seventh postoperative day was performed daily according to the European Society of critical care (2012) guidelines for AGI. Determined the severity with grade 1-4,The higher the score, the more serious it is.

Secondary Outcome Measures

Name	Time	Method
Return Time of Bowel Sounds	1 month	The time to first detection of bowel sounds after surgery, monitored daily in the morning and evening by auscultation.
Frequency of Bowel Sounds	1 month	The number of bowel sounds counted at 12-hour intervals, recorded twice daily to assess gastrointestinal motility.
Time to First Defecation	1 month	The time to the first defecation was asked morning and evening after surgery.
Proportion of Cocci and Bacilli in Feces	1 month	Analysis of bacterial composition in the first stool sample post-surgery, focusing on the ratio of cocci to bacilli.
5.C-Reactive Protein (CRP)	1 month	Maximum CRP level recorded within the first week after surgery.
Procalcitonin (PCT)	1 month	Maximum PCT level recorded within the first week after surgery.
Alanine Aminotransferase (ALT)	1 month	The investigators defined it as the maximum value of ALT within 7 days after surgery.
Aspartate Aminotransferase (AST)	1 month	The investigators defined it as the maximum value of ALT within 7 days after surgery.
Creatinine	1 month	The investigators defined it as the maximum value of Creatinine within 7 days after surgery.
Left Ventricular Ejection Fraction (LVEF)	1 month	LVEF assessed through echocardiography on days 1 and 3 post-surgery to monitor cardiac function.
Ventilator assisted time (VAT)	1 month	VAT was defined as the sum time of ventilator assisted post-surgery.
Days of ICU stay	3 months	Total number of days during ICU, reflecting overall recovery and the impact of any gastrointestinal or systemic complications.

Trial Locations

Locations (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province; 🇨🇳 Lanzhou, Gansu, China