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

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.

Study Overview

• Status: Completed
• Conditions: Valvular Disease
• Intervention / Treatment: Other: Prolonged ≥ 120 minutes

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 Type: Observational
• Enrollment (Actual): 1444

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Hepatopancreatobiliary Surgery Institute of Gansu Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing heart valve replacement with differ CPB durations.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CPB time ≥ 120 minutes; Patients will be grouped into a prolonged CPB group (CPB ≥120 minutes)	Other: Prolonged ≥ 120 minutes; No intervention, regular therapy
CPB time < 120 minutes; Patients will be grouped into a normal CPB group (CPB <120 minutes) .	Other: Prolonged ≥ 120 minutes; No intervention, regular therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The acute gastrointestinal injury (AGI) score	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.	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Investigators: Principal Investigator: Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province

Publications and helpful links

General Publications

• Reintam Blaser A, Malbrain ML, Starkopf J, Fruhwald S, Jakob SM, De Waele J, Braun JP, Poeze M, Spies C. Gastrointestinal function in intensive care patients: terminology, definitions and management. Recommendations of the ESICM Working Group on Abdominal Problems. Intensive Care Med. 2012 Mar;38(3):384-94. doi: 10.1007/s00134-011-2459-y. Epub 2012 Feb 7.
• Gallitto E, Sobocinski J, Mascoli C, Pini R, Fenelli C, Faggioli G, Haulon S, Gargiulo M. Fenestrated and Branched Thoraco-abdominal Endografting after Previous Open Abdominal Aortic Repair. Eur J Vasc Endovasc Surg. 2020 Dec;60(6):843-852. doi: 10.1016/j.ejvs.2020.07.071. Epub 2020 Aug 24.
• Seilitz J, Edstrom M, Skoldberg M, Westerling-Andersson K, Kasim A, Renberg A, Jansson K, Friberg O, Axelsson B, Nilsson KF. Early Onset of Postoperative Gastrointestinal Dysfunction Is Associated With Unfavorable Outcome in Cardiac Surgery: A Prospective Observational Study. J Intensive Care Med. 2021 Nov;36(11):1264-1271. doi: 10.1177/0885066620946006. Epub 2020 Aug 10.
• Yang X, Lu N, Yang L, Li B, Zhou W, Li Y, Song B, Yuan J, Meng W. Impact of prolonged cardiopulmonary bypass on gastrointestinal complications in cardiac surgery: a retrospective cohort study. Perioper Med (Lond). 2025 Apr 15;14(1):42. doi: 10.1186/s13741-025-00524-w.

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2024
• Primary Completion (Actual): December 25, 2025
• Study Completion (Actual): December 25, 2025

Study Registration Dates

• First Submitted: November 16, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Complications; Cardiopulmonary bypass; Valvular disease; Gastrointestinal injury
• Other Study ID Numbers: CPB-GICs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No