Impact of Cardiopulmonary Bypass Time on Gastrointestinal Complications

NCT06697405 | Completed DMC

• 1 other identifier: CPB-GICs
• Study Type: observational
• Target: 1,444
• Locations: 1 country
• Sites: 1

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.

Conditions

Valvular Disease

Keywords

Cardiopulmonary bypass; Gastrointestinal injury; Valvular disease; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Return Time of Bowel Sounds

  1 month

• Frequency of Bowel Sounds

  1 month

• Time to First Defecation

  1 month

• Proportion of Cocci and Bacilli in Feces

  1 month

• 5.C-Reactive Protein (CRP)

  1 month

Study Arms (2)

CPB time ≥ 120 minutes

Patients will be grouped into a prolonged CPB group (CPB ≥120 minutes)

Other: Prolonged ≥ 120 minutes

CPB time < 120 minutes

Patients will be grouped into a normal CPB group (CPB \<120 minutes) .

Other: Prolonged ≥ 120 minutes

Interventions

Prolonged ≥ 120 minutes OTHER

No intervention, regular therapy

CPB time < 120 minutes; CPB time ≥ 120 minutes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing heart valve replacement with differ CPB durations.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead

Study Sites (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

Location

Related Publications (4)

• 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.

  PMID: 32855033 BACKGROUND

• 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.

  PMID: 32772778 BACKGROUND

• 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.

  PMID: 22310869 BACKGROUND

• 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.

  PMID: 40234981 DERIVED

Study Officials

• Wenbo Meng

  Hepatopancreatobiliary Surgery Institute of Gansu Province

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Surgery

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: November 20, 2024
• Study Start: December 24, 2024
• Primary Completion: December 25, 2025
• Study Completion: December 25, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)