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Biomarkers and Bowel Sounds in Patients With Acute Gastrointestinal Injury (BABSIPWAGI)

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ClinicalTrials.gov Identifier: NCT04769830
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : August 23, 2021
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Study Description
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Brief Summary:
The incidence of gastrointestinal diseases is high in intensive care unit (intensive care unit,ICU). In critically ill patients, the intestinal tract is the "engine" of multiple organ dysfunction syndrome (Multiple organ dysfunction syndrome,MODS) and a component of multiple organ dysfunction syndrome, which is closely related to the poor prognosis of critically ill patients. In 2012, the abdominal working group of the European Association of critical Care Medicine (the European Society of Intensive Care Medicine,ESICM) put forward the concept of "acute gastrointestinal injury" (acute gastrointestinal injury,AGI), which was defined as gastrointestinal dysfunction caused by acute disease in critically ill patients. However, the grading system is complex and general, which does not reflect other gastrointestinal functions such as endocrine, immunity, barrier and so on, and lacks the support of objective laboratory results. When patients with acute gastrointestinal injury, gastrointestinal digestion and absorption, endocrine, immunity, barrier function are affected in varying degrees. The levels of indexes reflecting gastrointestinal digestion and absorption, endocrine and immunity were different among different AGI grades. The purpose of this study was to observe the characteristics of AGI bowel sounds in critically ill patients with ICU by digital continuous bowel sound monitoring, and to explore the clinical value of bowel sounds characteristics in AGI of critically ill patients combined with the changes of biomarkers of gastrointestinal injury.

Condition or disease Intervention/treatment
Gastrointestinal Injury Other: Bowel sound

Detailed Description:
In this study, digital bowel sound monitoring equipment was used to continuously monitor the bowel sound of critically ill patients with ICU. This technology added the intestinal sound characteristic database to the data processing center, analyzed and identified the intestinal sound data through the intestinal sound recognition algorithm, further analyzed the parameters such as audio frequency, spectrum and power spectrum, and observed the changes of biomarkers such as citrulline and intestinal fatty acid binding protein.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 172 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: Study on the Value of Digital Continuous Bowel Sound Monitoring in AGI of Critically Ill Patients With ICU
Actual Study Start Date : April 14, 2021
Estimated Primary Completion Date : January 25, 2022
Estimated Study Completion Date : June 25, 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
AGI group
Collect the characteristic data of intestinal sound, such as 24-hour average intestinal rate, duration of gastrointestinal sound, amplitude, maximum frequency, average frequency, etc., and detect citrulline, intestinal fatty acid binding protein and so on.
 Other: Bowel sound
The characteristic data of bowel sounds, such as 24-hour average intestinal rate, duration of gastrointestinal sounds, amplitude, maximum frequency and average frequency, were collected to observe the differences of intestinal sounds among different AGI grades.
non-AGI group
Collect the characteristic data of intestinal sound, such as 24-hour average intestinal rate, duration of gastrointestinal sound, amplitude, maximum frequency, average frequency, etc., and detect citrulline, intestinal fatty acid binding protein and so on.
 Other: Bowel sound
The characteristic data of bowel sounds, such as 24-hour average intestinal rate, duration of gastrointestinal sounds, amplitude, maximum frequency and average frequency, were collected to observe the differences of intestinal sounds among different AGI grades.


Outcome Measures
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Primary Outcome Measures :
  1. Changes of 24-hour average intestinal sound rate [ Time Frame: Days 1, 2, 3, 7 ]
    Times per minute


Secondary Outcome Measures :
  1. Changes of citrulline level [ Time Frame: Days 1, 2, 3, 7 ]
    μmol/L

  2. Changes of intestinal fatty acid binding protein level [ Time Frame: Days 1, 2, 3, 7 ]
    ng/L

  3. Changes of motilin level [ Time Frame: Days 1, 2, 3, 7 ]
    ng/L

  4. Changes of gastrin level [ Time Frame: Days 1, 2, 3, 7 ]
    ng/L


Biospecimen Retention:   Samples Without DNA
Citrulline，Intestinal fatty acid binding protein and so on.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The critically ill patients treated in the Department of intensive Care of the first affiliated Hospital of Xi'an Jiaotong University were selected as the sample source.
Criteria

Inclusion Criteria:

  • Patients ≥ 18 years old and ≤ 80 years old.
  • The time of staying in ICU is expected to be more than 48 hours.
  • The patient or legal guardian or legal representative signs the informed consent form.

Exclusion Criteria:

  • It is estimated that the hospitalization time of ICU is less than 24 hours, and the case data are incomplete.
  • Age > 80 years old; patients with chronic or primary gastrointestinal diseases (such as Crohn's disease, ulcerative colitis, gastrointestinal ulcer), short bowel syndrome, gastrointestinal surgery (history of partial or total gastrectomy), malignant tumor.
  • Pregnant or lactating women.
  • Patients with severe cardiovascular disease and hemodynamic instability may have cardiorespiratory arrest in a short period of time.
  • The patient himself or the agent refused to sign the informed consent form or participate in another clinical trial.
  • The researchers determined that other conditions in which the patient was not suitable for selection.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04769830


Contacts
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Contact: Qindong Shi, Senior 0086-18991232391 shiqindong@163.com
Contact: Yuanhui Sun, Junior 0086-18091991284 2370247462@qq.com

Locations
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China, Shaanxi
First Affiliated Hospital of Xian JiaotongUniversity Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Qindong Shi, Senior    0086-18991232391    shiqindong@163.com   
Contact: Yuanhui Sun, Junior    0086-18091991284    2370247462@qq.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Study Chair: Qindong Shi, Chief Director of intensive Care Unit
More Information
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT04769830    
Other Study ID Numbers: XJTU1AF2021LSK-013
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
biomarkers
Continuous bowel sound detection
Critically ill patients
Additional relevant MeSH terms:
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Wounds and Injuries