Valvular DiseaseNCT06697405
Impact of Cardiopulmonary Bypass Time on Gastrointestinal Complications
An observational study of Valvular Disease, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Valvular Disease
- What is being tested?
- Prolonged ≥ 120 minutes
- How many people
- 1,444 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2024to 25 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing heart valve replacement with differ CPB durations.
Who may be able to join
- Patients undergoing heart valve replacement with CPB
- Age ≥ 18 years and ≤ 75 years
Who cannot join
- 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.
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000
About this study
Official title: Incidence, Risk Factors, and Outcomes of Gastrointestinal Complications in Patients Undergoing Heart Valve Replacement With Cardiopulmonary Bypass
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.
Read the 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.
- Conditions
- Valvular Disease
- Being tested
- Prolonged ≥ 120 minutes
- Keywords
- Cardiopulmonary bypass, Gastrointestinal injury, Valvular disease, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged ≥ 120 minutesOther
No intervention, regular therapy
| Study group | Role | What they receive |
|---|---|---|
| CPB time ≥ 120 minutes | Patients will be grouped into a prolonged CPB group (CPB ≥120 minutes) Receives: Other: Prolonged ≥ 120 minutes | |
| CPB time < 120 minutes | Patients will be grouped into a normal CPB group (CPB <120 minutes) . Receives: Other: Prolonged ≥ 120 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
The acute gastrointestinal injury (AGI) score
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.
Measured: 1 month
Secondary outcomes (12)
Return Time of Bowel Sounds
The time to first detection of bowel sounds after surgery, monitored daily in the morning and evening by auscultation.
Measured: 1 month
Frequency of Bowel Sounds
The number of bowel sounds counted at 12-hour intervals, recorded twice daily to assess gastrointestinal motility.
Measured: 1 month
Time to First Defecation
The time to the first defecation was asked morning and evening after surgery.
Measured: 1 month
Proportion of Cocci and Bacilli in Feces
Analysis of bacterial composition in the first stool sample post-surgery, focusing on the ratio of cocci to bacilli.
Measured: 1 month
5.C-Reactive Protein (CRP)
Maximum CRP level recorded within the first week after surgery.
Measured: 1 month
Procalcitonin (PCT)
Maximum PCT level recorded within the first week after surgery.
Measured: 1 month
Alanine Aminotransferase (ALT)
The investigators defined it as the maximum value of ALT within 7 days after surgery.
Measured: 1 month
Aspartate Aminotransferase (AST)
The investigators defined it as the maximum value of ALT within 7 days after surgery.
Measured: 1 month
Creatinine
The investigators defined it as the maximum value of Creatinine within 7 days after surgery.
Measured: 1 month
Left Ventricular Ejection Fraction (LVEF)
LVEF assessed through echocardiography on days 1 and 3 post-surgery to monitor cardiac function.
Measured: 1 month
Ventilator assisted time (VAT)
VAT was defined as the sum time of ventilator assisted post-surgery.
Measured: 1 month
Days of ICU stay
Total number of days during ICU, reflecting overall recovery and the impact of any gastrointestinal or systemic complications.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start24 Dec 2024
- Primary completion25 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Valvular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Wenbo Meng, Principal investigator, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697405
- Sponsor's protocol ID
- CPB-GICs
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32855033Seilitz 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.
PubMed 32772778Reintam 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.
PubMed 22310869Yang 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.
PubMed 40234981
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors, and Outcomes of Gastrointestinal Complications in Patients Undergoing Heart Valve Replacement With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT06697405
- Acronym / sponsor ID
- CPB-GICs
- Conditions
- Valvular Disease
- Keywords
- Cardiopulmonary bypass, Gastrointestinal injury, Valvular disease, Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,444 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPB time ≥ 120 minutes | – | Other: Prolonged ≥ 120 minutesPatients will be grouped into a prolonged CPB group (CPB ≥120 minutes) |
| CPB time < 120 minutes | – | Other: Prolonged ≥ 120 minutesPatients will be grouped into a normal CPB group (CPB <120 minutes) . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing heart valve replacement with differ CPB durations.
Key inclusion criteria (2 listed)
- Patients undergoing heart valve replacement with CPB
- Age ≥ 18 years and ≤ 75 years
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged ≥ 120 minutesNo intervention, regular therapy | Other | CPB time < 120 minutes, CPB time ≥ 120 minutes |
Primary outcome
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.
12 secondary outcomes
Return Time of Bowel Sounds
Time frame: 1 month
Frequency of Bowel Sounds
Time frame: 1 month
Time to First Defecation
Time frame: 1 month
Proportion of Cocci and Bacilli in Feces
Time frame: 1 month
5.C-Reactive Protein (CRP)
Time frame: 1 month
Procalcitonin (PCT)
Time frame: 1 month
Alanine Aminotransferase (ALT)
Time frame: 1 month
Aspartate Aminotransferase (AST)
Time frame: 1 month
Creatinine
Time frame: 1 month
Left Ventricular Ejection Fraction (LVEF)
Time frame: 1 month
Ventilator assisted time (VAT)
Time frame: 1 month
Days of ICU stay
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Background: PubMed 32855033Gallitto 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.
- Background: PubMed 32772778Seilitz 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.
- Background: PubMed 22310869Reintam 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.
- Derived from this study: PubMed 40234981Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenbo Meng principal investigator
Hepatopancreatobiliary Surgery Institute of Gansu Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Disease, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The acute gastrointestinal injury (AGI) score (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06697405, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.