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Impact of Cardiopulmonary Bypass Time on Gastrointestinal Complications

H

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status

Completed

Conditions

Valvular Disease

Treatments

Other: Prolonged ≥ 120 minutes

Study type

Observational

Funder types

Other

Identifiers

NCT06697405
CPB-GICs

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,444 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,444 participants in 2 patient groups

CPB time ≥ 120 minutes
Description:
Patients will be grouped into a prolonged CPB group (CPB ≥120 minutes)
Treatment:
Other: Prolonged ≥ 120 minutes
CPB time < 120 minutes
Description:
Patients will be grouped into a normal CPB group (CPB \<120 minutes) .
Treatment:
Other: Prolonged ≥ 120 minutes

Trial contacts and locations

1

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Central trial contact

Wenbo Meng

Data sourced from clinicaltrials.gov

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