MedDataX Logo

Impact of Cardiopulmonary Bypass Time on Gastrointestinal Complications

NCT ID: NCT06697405

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-24

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Valvular Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cardiopulmonary bypass Gastrointestinal injury Valvular disease Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CPB time ≥ 120 minutes

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

Prolonged ≥ 120 minutes

Intervention Type OTHER

No intervention, regular therapy

CPB time < 120 minutes

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

Prolonged ≥ 120 minutes

Intervention Type OTHER

No intervention, regular therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prolonged ≥ 120 minutes

No intervention, regular therapy

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wenbo Meng

Director of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wenbo Meng

Role: PRINCIPAL_INVESTIGATOR

Hepatopancreatobiliary Surgery Institute of Gansu Province

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wenbo Meng

Role: CONTACT

Phone: 13919177177

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xiaofang Yang, MD,PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32855033 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32772778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22310869 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40234981 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CPB-GICs

Identifier Type: -

Identifier Source: org_study_id