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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06697405
Enrollment
1444
Registered
2024-11-20
Start date
2024-12-24
Completion date
2025-12-25
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular Disease

Keywords

Cardiopulmonary bypass, Gastrointestinal injury, Valvular disease, Complications

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.

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.

Interventions

OTHERProlonged ≥ 120 minutes

No intervention, regular therapy

Sponsors

Hepatopancreatobiliary Surgery Institute of Gansu Province
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The acute gastrointestinal injury (AGI) score1 monthThe 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

MeasureTime frameDescription
Procalcitonin (PCT)1 monthMaximum PCT level recorded within the first week after surgery.
Time to First Defecation1 monthThe time to the first defecation was asked morning and evening after surgery.
Proportion of Cocci and Bacilli in Feces1 monthAnalysis of bacterial composition in the first stool sample post-surgery, focusing on the ratio of cocci to bacilli.
Return Time of Bowel Sounds1 monthThe time to first detection of bowel sounds after surgery, monitored daily in the morning and evening by auscultation.
Frequency of Bowel Sounds1 monthThe number of bowel sounds counted at 12-hour intervals, recorded twice daily to assess gastrointestinal motility.
5.C-Reactive Protein (CRP)1 monthMaximum CRP level recorded within the first week after surgery.
Aspartate Aminotransferase (AST)1 monthThe investigators defined it as the maximum value of ALT within 7 days after surgery.
Creatinine1 monthThe investigators defined it as the maximum value of Creatinine within 7 days after surgery.
Left Ventricular Ejection Fraction (LVEF)1 monthLVEF assessed through echocardiography on days 1 and 3 post-surgery to monitor cardiac function.
Ventilator assisted time (VAT)1 monthVAT was defined as the sum time of ventilator assisted post-surgery.
Days of ICU stay3 monthsTotal number of days during ICU, reflecting overall recovery and the impact of any gastrointestinal or systemic complications.
Alanine Aminotransferase (ALT)1 monthThe investigators defined it as the maximum value of ALT within 7 days after surgery.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026