Biomarkers and Bowel Sounds in Patients With Acute Gastrointestinal Injury

NCT04769830 | Unknown

• 1 other identifier: XJTU1AF2021LSK-013
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Injury

Keywords

biomarkers; Continuous bowel sound detection; Critically ill patients

Outcome Measures

Primary Outcomes (1)

• Changes of 24-hour average intestinal sound rate

  Times per minute

  Days 1, 2, 3, 7

Secondary Outcomes (4)

• Changes of citrulline level

  Days 1, 2, 3, 7

• Changes of intestinal fatty acid binding protein level

  Days 1, 2, 3, 7

• Changes of motilin level

  Days 1, 2, 3, 7

• Changes of gastrin level

  Days 1, 2, 3, 7

Study Arms (2)

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

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

Interventions

Bowel sound OTHER

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.

AGI group; non-AGI group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Citrulline，Intestinal fatty acid binding protein and so on.

Study Officials

• Qindong Shi, Chief

  Director of intensive Care Unit

  STUDY CHAIR

Central Study Contacts

Qindong Shi, Senior

CONTACT

0086-18991232391; shiqindong@163.com

Yuanhui Sun, Junior

CONTACT

0086-18091991284; 2370247462@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 25, 2021
• Study Start: April 14, 2021
• Primary Completion: September 25, 2022
• Study Completion: September 25, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-05

Locations

CN (1)