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Completed

NCT Number: NCT06697405

Impact of Cardiopulmonary Bypass Time on Gastrointestinal Complications

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prolonged ≥ 120 minutes

Other

No intervention, regular therapy

Primary outcomes

  1. The acute gastrointestinal injury (AGI) score

    Time frame: 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 outcomes

  1. Return Time of Bowel Sounds

    Time frame: 1 month

    The time to first detection of bowel sounds after surgery, monitored daily in the morning and evening by auscultation.

  2. Frequency of Bowel Sounds

    Time frame: 1 month

    The number of bowel sounds counted at 12-hour intervals, recorded twice daily to assess gastrointestinal motility.

  3. Time to First Defecation

    Time frame: 1 month

    The time to the first defecation was asked morning and evening after surgery.

  4. Proportion of Cocci and Bacilli in Feces

    Time frame: 1 month

    Analysis of bacterial composition in the first stool sample post-surgery, focusing on the ratio of cocci to bacilli.

  5. 5.C-Reactive Protein (CRP)

    Time frame: 1 month

    Maximum CRP level recorded within the first week after surgery.

  6. Procalcitonin (PCT)

    Time frame: 1 month

    Maximum PCT level recorded within the first week after surgery.

  7. Alanine Aminotransferase (ALT)

    Time frame: 1 month

    The investigators defined it as the maximum value of ALT within 7 days after surgery.

  8. Aspartate Aminotransferase (AST)

    Time frame: 1 month

    The investigators defined it as the maximum value of ALT within 7 days after surgery.

  9. Creatinine

    Time frame: 1 month

    The investigators defined it as the maximum value of Creatinine within 7 days after surgery.

  10. Left Ventricular Ejection Fraction (LVEF)

    Time frame: 1 month

    LVEF assessed through echocardiography on days 1 and 3 post-surgery to monitor cardiac function.

  11. Ventilator assisted time (VAT)

    Time frame: 1 month

    VAT was defined as the sum time of ventilator assisted post-surgery.

  12. Days of ICU stay

    Time frame: 3 months

    Total number of days during ICU, reflecting overall recovery and the impact of any gastrointestinal or systemic complications.

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

Incidence, Risk Factors, and Outcomes of Gastrointestinal Complications in Patients Undergoing Heart Valve Replacement With Cardiopulmonary Bypass

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2024
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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