Impact of Cardiopulmonary Bypass Time on Gastrointestinal Complications (NCT06697405) | Clinical Trial Compass
CompletedNot Applicable
Impact of Cardiopulmonary Bypass Time on Gastrointestinal Complications
China1,444 participantsStarted 2024-12-24
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The acute gastrointestinal injury (AGI) score
Timeframe: 1 month
Trial details
NCT IDNCT06697405
SponsorHepatopancreatobiliary Surgery Institute of Gansu Province