Prolonged Cardiopulmonary Bypass Time as a Predictive Factor for AGI After Heart Valve Replacement

January 2, 2024 updated by: Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1070

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Hepatopancreatobiliary Surgery Institute of Gansu Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Heart valve diseases

Description

Inclusion Criteria:

  • Patients undergoing heart valve replacement surgery with CPB
  • Age > 18 years and ≤ 70 years

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CPB time ≥ 90 minutes
No intervention, regular therapy
Other: CPB time
Cardiopulmonary bypass time
CPB time < 90 minutes
No intervention, regular therapy
Other: CPB time
Cardiopulmonary bypass time

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiopulmonary bypass (CPB) time
Time Frame: 1 month
Was defined it as the sum of times of CPB during surgery (minutes).
1 month
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.
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of bowel sounds
Time Frame: 1 month
The return time of bowel sounds was evaluated morning and evening.
1 month
First defecation time
Time Frame: 1 month
The time to the first defecation was asked morning and evening after surgery
1 month
Proportion of cocci and bacilli in feces
Time Frame: 1 month
The first feces were collected in sterile containers for the bacterial smear
1 month
Alanine aminotransferase (ALT)
Time Frame: 1 month
We defined it as the maximum value of ALT within 7 days after surgery.
1 month
Aspartate aminotransferase (AST)
Time Frame: 1 month
We defined it as the maximum value of AST within 7 days after surgery
1 month
Left ventricular ejection fraction (LVEF)
Time Frame: 1 month
We measured the LVEF on the 1st and 3rd days after operation by echocardiographic examinations
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hepatopancreatobiliary Surgery Institute of Gansu Province

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wenbo Meng, M.D. Ph.D, LanZhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPB-AGI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

If patients permitted

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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