Heart Valve DiseasesNCT05498935
Prolonged Cardiopulmonary Bypass Time as a Predictive Factor for AGI After Heart Valve Replacement
An observational study of Heart Valve Diseases, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
Trial summary
In this retrospective study, the investigators will analyze the correlation between cardiopulmonary bypass (CPB) time and acute gastrointestinal injury (AGI), and the outcomes of AGI in patients undergoing heart valve replacement. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- CPB time
- How many people
- 1,070 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2022to 2 Jan 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart valve diseases
Who may be able to join
- Patients undergoing heart valve replacement surgery with CPB
- Age > 18 years and ≤ 70 years
Who cannot join
- Patients combined with severe hematological disease, respiratory disease, and other critical diseases
- Patients had severe disorder of multiple systems and organs or severe pulmonary hypertension
- Have received major gastrointestinal surgery within 5 years
- Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis
- Acute gastroenteritis
- Clostridium difficile or Helicobacter pylori infection
Show all 15Show fewer
- 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 during surgery
- Patients with digestive system tumors
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: Prolonged Cardiopulmonary Bypass (CPB) Time as a Predictive Factor for Acute Gastrointestinal Injury (AGI) After Heart Valve Replacement
In this retrospective study, the investigators will analyze the correlation between cardiopulmonary bypass (CPB) time and acute gastrointestinal injury (AGI), and the outcomes of AGI in patients undergoing heart valve replacement.
Read the detailed description
Patients with heart valve diseases often have chronic cardiac insufficiency. Patients undergoing heart valve replacement with CPB are always complicated with gastrointestinal tract ischemia-reperfusion injury, which usually leads to AGI. AGI after cardiovascular surgery, especially in that use CPB, is associated with significant morbidity and an increase in peri-operative mortality. Prolonged CPB time could be predictive of AGI following heart valve replacement. This study is to analyze the correlation between CPB time and AGI, and the outcomes of AGI in patients undergoing heart valve replacement. The investigators hope that the benefits will include fewer patients becoming seriously postoperative AGI and mortality after cardiac surgery.
- Conditions
- Heart Valve Diseases
- Being tested
- CPB time
- Keywords
- Heart valve diseases, Gastrointestinal tract
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPB timeOther
Cardiopulmonary bypass time
| Study group | Role | What they receive |
|---|---|---|
| CPB time ≥ 90 minutes | No intervention, regular therapy Receives: Other: CPB time | |
| CPB time < 90 minutes | No intervention, regular therapy Receives: Other: CPB time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary bypass (CPB) time
Was defined it as the sum of times of CPB during surgery (minutes).
Measured: 1 month
The AGI score
The AGI score of the patient within the seventh postoperative day was performed according to the European Society of critical care (2012) guidelines for AGI.
Measured: 1 month
Secondary outcomes (6)
Number of bowel sounds
The return time of bowel sounds was evaluated morning and evening.
Measured: 1 month
First defecation time
The time to the first defecation was asked morning and evening after surgery
Measured: 1 month
Proportion of cocci and bacilli in feces
The first feces were collected in sterile containers for the bacterial smear
Measured: 1 month
Alanine aminotransferase (ALT)
We defined it as the maximum value of ALT within 7 days after surgery.
Measured: 1 month
Aspartate aminotransferase (AST)
We defined it as the maximum value of AST within 7 days after surgery
Measured: 1 month
Left ventricular ejection fraction (LVEF)
We measured the LVEF on the 1st and 3rd days after operation by echocardiographic examinations
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start10 Aug 2022
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies 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
- 1,070 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, M.D. Ph.D, Principal investigator, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498935
- Sponsor's protocol ID
- CPB-AGI
- Status last verified
- Jan 2024
- First submitted
- 10 Aug 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If patients permitted
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 32855033Buchbinder A, Adler H, Ballard H. An unusual and unreported toxicity to erythropoietin. Am J Hematol. 1993 Apr;42(4):412-3. doi: 10.1002/ajh.2830420428. No abstract available.
PubMed 8494005
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Cardiopulmonary Bypass (CPB) Time as a Predictive Factor for Acute Gastrointestinal Injury (AGI) After Heart Valve Replacement
- ClinicalTrials.gov ID
- NCT05498935
- Acronym / sponsor ID
- CPB-AGI
- Conditions
- Heart Valve Diseases
- Keywords
- Heart valve diseases, Gastrointestinal tract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,070 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 12 Aug 2022 (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.
In this retrospective study, the investigators will analyze the correlation between cardiopulmonary bypass (CPB) time and acute gastrointestinal injury (AGI), and the outcomes of AGI in patients undergoing heart valve replacement.
Detailed description
Patients with heart valve diseases often have chronic cardiac insufficiency. Patients undergoing heart valve replacement with CPB are always complicated with gastrointestinal tract ischemia-reperfusion injury, which usually leads to AGI. AGI after cardiovascular surgery, especially in that use CPB, is associated with significant morbidity and an increase in peri-operative mortality. Prolonged CPB time could be predictive of AGI following heart valve replacement. This study is to analyze the correlation between CPB time and AGI, and the outcomes of AGI in patients undergoing heart valve replacement. The investigators hope that the benefits will include fewer patients becoming seriously postoperative AGI and mortality after cardiac surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPB time ≥ 90 minutes | – | Other: CPB timeNo intervention, regular therapy |
| CPB time < 90 minutes | – | Other: CPB timeNo intervention, regular therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart valve diseases
Key inclusion criteria (2 listed)
- Patients undergoing heart valve replacement surgery with CPB
- Age > 18 years and ≤ 70 years
Key exclusion criteria (15 listed)
- Patients combined with severe hematological disease, respiratory disease, and other critical diseases
- Patients had severe disorder of multiple systems and organs or severe pulmonary hypertension
- Have received major gastrointestinal surgery within 5 years
- Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis
- Acute gastroenteritis
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 |
|---|---|---|
| CPB timeCardiopulmonary bypass time | Other | CPB time < 90 minutes, CPB time ≥ 90 minutes |
Primary outcome
Cardiopulmonary bypass (CPB) time
Time frame: 1 month
Was defined it as the sum of times of CPB during surgery (minutes).
The AGI score
Time frame: 1 month
The AGI score of the patient within the seventh postoperative day was performed according to the European Society of critical care (2012) guidelines for AGI.
6 secondary outcomes
Number of bowel sounds
Time frame: 1 month
First defecation time
Time frame: 1 month
Proportion of cocci and bacilli in feces
Time frame: 1 month
Alanine aminotransferase (ALT)
Time frame: 1 month
Aspartate aminotransferase (AST)
Time frame: 1 month
Left ventricular ejection fraction (LVEF)
Time frame: 1 month
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 3 Jan 2024.
- Results publication: 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.
- Results publication: PubMed 8494005Buchbinder A, Adler H, Ballard H. An unusual and unreported toxicity to erythropoietin. Am J Hematol. 1993 Apr;42(4):412-3. doi: 10.1002/ajh.2830420428. No abstract available.
- Individual participant dataSharing planned: Undecided. If patients permitted
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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, M.D. Ph.D principal investigator
LanZhou University
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 Heart Valve Diseases, 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 15 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 3 Jan 2024. 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?
Cardiopulmonary bypass (CPB) time (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT05498935, which also lists 2 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 3 Jan 2024.