Gastrointestinal InjuryBABSIPWAGINCT04769830
Biomarkers and Bowel Sounds in Patients With Acute Gastrointestinal Injury
An observational study of Gastrointestinal Injury, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Injury
- What is being tested?
- Bowel sound
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2021to 25 Sep 2022
- How long will I take part?
- 28 Days
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, 710061
Qindong Shi, Senior, 0086-18991232391, shiqindong@163.com
Yuanhui Sun, Junior, 0086-18091991284, 2370247462@qq.com
About this study
Official title: Study on the Value of Digital Continuous Bowel Sound Monitoring in AGI of Critically Ill Patients With ICU
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.
Read the 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.
- Conditions
- Gastrointestinal Injury
- Being tested
- Bowel sound
- Keywords
- biomarkers, Continuous bowel sound detection, Critically ill patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel soundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Bowel sound | |
| 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. Receives: Other: Bowel sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of 24-hour average intestinal sound rate
Times per minute
Measured: Days 1, 2, 3, 7
Secondary outcomes (4)
Changes of citrulline level
μmol/L
Measured: Days 1, 2, 3, 7
Changes of intestinal fatty acid binding protein level
ng/L
Measured: Days 1, 2, 3, 7
Changes of motilin level
ng/L
Measured: Days 1, 2, 3, 7
Changes of gastrin level
ng/L
Measured: Days 1, 2, 3, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start14 Apr 2021
- Primary completion25 Sep 2022 (estimated)
- Study completion25 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal InjuryStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qindong Shi, Chief, Study chair, Director of intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769830
- Sponsor's protocol ID
- XJTU1AF2021LSK-013
- Acronym
- BABSIPWAGI
- Status last verified
- May 2022
- First submitted
- 6 Feb 2021
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Value of Digital Continuous Bowel Sound Monitoring in AGI of Critically Ill Patients With ICU
- ClinicalTrials.gov ID
- NCT04769830
- Acronym / sponsor ID
- BABSIPWAGI / XJTU1AF2021LSK-013
- Conditions
- Gastrointestinal Injury
- Keywords
- biomarkers, Continuous bowel sound detection, Critically ill patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 25 Sep 2022 (estimated)
- Study completion
- 25 Sep 2022 (estimated)
- First posted
- 25 Feb 2021 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGI group | – | Other: Bowel soundCollect 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. |
| non-AGI group | – | Other: Bowel soundCollect 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Bowel soundThe 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. | Other | AGI group, non-AGI group |
Primary outcome
Changes of 24-hour average intestinal sound rate
Time frame: Days 1, 2, 3, 7
Times per minute
4 secondary outcomes
Changes of citrulline level
Time frame: Days 1, 2, 3, 7
Changes of intestinal fatty acid binding protein level
Time frame: Days 1, 2, 3, 7
Changes of motilin level
Time frame: Days 1, 2, 3, 7
Changes of gastrin level
Time frame: Days 1, 2, 3, 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
Related trials for Gastrointestinal Injury
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Onyx™ Liquid Embolic IDE Clinical Study
Peripheral Arterial Hemorrhage, Trauma
RecruitingObservational study
Microbiome and Enteric Signatures in Sepsis-associated Hepatorenal Injury
Sepsis, Acute Kidney Injury Due to Sepsis
RecruitingPhase 1/2
The Effects of SCFA Supplementation in Subjects Receiving Abdominopelvic RT: A Randomized Controlled Study
Toxicity, Radiation Toxicity
Not yet recruitingPhase 3
A Study of Chlorophyllin or Placebo With Standard Treatment for Late Radiation Induced Luminal Gastrointestinal Tract Bleeding
Radiation Proctitis, Gastrointestinal Hemorrhage
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.
Qindong Shi, Chief study chair
Director of intensive Care Unit
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 Gastrointestinal Injury, run by First Affiliated Hospital Xi'an Jiaotong University 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qindong Shi, Senior (0086-18991232391, shiqindong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of 24-hour average intestinal sound rate (time frame: Days 1, 2, 3, 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.