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Gut Microbiota2022-11-09NCT05628493

Gut Microbiota Analysis in IAI Patients With Sepsis-associated Liver Dysfunction

An observational study of Gut Microbiota and Intra-abdominal Infections, run by Chinese Medical Association at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

With the rapid development of intensive care medicine, the mortality of patients with sepsis has decreased over the past decade, but it is still the leading cause of death in intensive care unit (ICU). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Gut microbiota Analysis
How many people
20 participants
Where
1 siteChina
Study dates
3 Jan 2022to 14 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: All patients diagnosed with intra-abdominal infection (IAI). IAI was diagnosed according to the 2005 International Sepsis Forum Consensus Conference. Briefly, the patient present with abdominal symptoms and signs, such as fever (≥38℃), tenderness, rebound pain, etc; elevated inflammatory indicators in peripheral blood and positive culture of intra-abdominal specimens.

Who may be able to join

  • Adult patients (≥18 years)
  • Diagnosed as Intra-abdominal infections (IAH)
  • Diagnosed as sepsis 3.0

Who cannot join

  • Discharged or died within 48 hours afterenrollment
  • Known serious chronic liver disease, such as decompensated cirrhosis and end-stage liver cancer
  • Hospitalization due to primary hepatobiliary disease, such as trauma, hepatitis, cholelithiasis, etc;
  • Other causes of liver injury include: drugs, poisons, etc
  • Pregnancy.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

Other trials in China

About this study

Official title: Gut Microbiota Analysis With Next-generation 16S rRNA Gene Sequencing in IAI Patients With Sepsis-associated Liver Dysfunction

With the rapid development of intensive care medicine, the mortality of patients with sepsis has decreased over the past decade, but it is still the leading cause of death in intensive care unit (ICU). As an important immune and metabolic organ, the liver plays a crucial role in host defense against invading pathogens and endotoxins, as well as maintenance of metabolic and immunological homeostasis. Some studies indicate that sepsis-associated liver dysfunction (SALD) has a substantial impact on the severity and prognosis of sepsis.

Intra-abdominal infections (IAI) are the second leading source of infection for sepsis after pneumonia in ICU, and are often related to high morbidity and mortality rates. Studies had found that the incidence of SALD in IAI patients was considerably higher than that of general population with sepsis. Moreover, the incidence of acute gastrointestinal injury (AGI) in IAI patients was also much higher than that in sepsis patients with other site infections, as well as the degree of AGI was more serious according to guidelines proposed by the European Society of Intensive Care Medicine (ESICM) in 2012. IAI can directly cause AGI, and a subset of patients usually progress to increased intra-abdominal pressure, which further aggravates AGI.

Read more

The pathogenesis of SALD remains unclear so far, and its mechanism is complicated and elusive. Nevertheless, the unique anatomical structure of the liver make it has close association with the gut, growing evidence indicates that the gut microbiota and related metabolites are related to several liver disease. In case of sepsis, gut microbiota disorder and low microbial diversity can cause severe liver injury. An important mechanism for this phenotype is the gut-liver axis, which refers to gut microbial metabolites and nutrients are transported to the liver through the portal vein and hepatic artery to maintain the healthy metabolism of liver.

Therefore, we initially conducted a retrospective study to investigate the relationship between the occurrence of AGI and SALD among IAI patients. Subsequently, a prospective study was performed to analyze and compare the diversity and composition of gut microbiota in IAI patients with or without SALD, respectively, and the dynamic changes in the gut microbiota during the first week after ICU admission were also investigated.

Read the detailed description

A retrospective cohort study was conducted involving sepsis patients with IAI treated in ICU department of Nanjing Drum Tower Hospital between April 2020 to April 2020. Adult patients (≥18 years) with IAI who met the criteria for sepsis 3.0 were included. The exclusion criteria included: discharged or died within 48 hours after ICU admission; known serious chronic liver disease, such as decompensated cirrhosis and end-stage liver cancer; hospitalization due to primary hepatobiliary disease, such as trauma, hepatitis, cholelithiasis, etc; other causes of liver injury include: drugs, poisons, etc; and pregnancy.The following data were collected within 24 hours after ICU admission: demographic Information: age, sex and comorbidity; the score of disease severity: Acute Physiology and Chronic Health Evaluation (APACHE) II score; Sequential Organ Failure Assessment (SOFA) score; the primary site of abdominal infection: upper or lower gastrointestinal tract, pancreas and others; laboratory indicators: white blood cells (WBC), percentage of neutrophils (N%), C-reactive protein (CRP), procalcitonin (PCT), human leukocyte antigen (HLA)-DR. Date during hospitalization were also collected: complications: respiratory failure, septic shock, acute kidney injury (AKI) and AGI; pathogenic bacteria of ascites culture; bacteremia or not; total parenteral nutrition (TPN) was given or not. Prognostic indicators included ICU length of stay (LOS), hospital LOS, ICU mortality, in-hospital mortality, and 28-day mortality were also recorded.SALD was diagnosed when the level of serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1000IU/L, or total bilirubin (TBIL) level >3mg/dL during hospitalization. IAI was diagnosed according to the 2005 International Sepsis Forum Consensus Conference. Briefly, the patient present with abdominal symptoms and signs, such as fever (≥38℃), tenderness, rebound pain, etc; elevated inflammatory indicators in peripheral blood and positive culture of intra-abdominal specimens. Sepsis 3.0 and septic shock were diagnosed according to Third International Consensus Definition for Sepsis and Septic Shock in 2016. AKI was diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guidelines. AGI diagnosis and grading are based on the ESICM recommendations in 2012.To further clarify the relationship between gut microbiota and SALD, we conducted a prospective observational study between April 2020 to April 2020 in our center. Eligible patients must fulfill the same criteria as above. Other exclusion criteria also include: with expected ICU LOS < 1 week; had participated in any other clinical trial; underwent enterostomy surgery; had chronic inflammatory bowel disease. All eligible patients were given antibiotics therapy, actively control infection source by puncture drainage or surgery if necessary, as well as other supportive therapy to maintain organ function. Moreover, fecal samples were collected per patient on days 1,3 and 7 after ICU admission. Other data collection and the definition of related diseases are the same as the above.

Being tested
Gut microbiota Analysis
Medical subject headings
Intraabdominal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gut microbiota AnalysisBehavioural

    fecal samples were collected per patient on days 1,3 and 7 after ICU admission. All eligible patients were given antibiotics therapy, actively control infection source by puncture drainage or surgery if necessary, as well as other supportive therapy to maintain organ function.

Study groups in NCT05628493
Study groupRoleWhat they receive
The non-SALD groupThe patient did not meet the SALD diagnosis during the study observation period. SALD was diagnosed when the level of serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1000IU/L, or total bilirubin (TBIL) level >3mg/dL during hospitalization.
Receives: Behavioral: Gut microbiota Analysis
The SALD groupThe patient's maximum values of ALT, AST, or TBIL during hospitalization reached any of the SALD criteria.
Receives: Behavioral: Gut microbiota Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mortality

    28day-mortality

    Measured: Day28 after enrollment

Secondary outcomes (2)
  1. Gastrointestinal function

    acute gastrointestinal injury (AGI)

    Measured: through study completion, an average of 7 days

  2. Gut microbiota

    analysis of gut microbiota by 16S rRNA sequencing

    Measured: days 1,3 and 7 after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2022
  2. Study start3 Jan 2022
  3. Primary completion9 Sep 2022
  4. Study completion14 Sep 2022

Resources

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
Cross-sectional
Enrolment
20 participants (actual)
Target duration
28 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT05628493
Sponsor's protocol ID
2022-11-09
Acronym
2022-11-09
Status last verified
Mar 2022
First submitted
9 Nov 2022
Last updated
28 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guo K, Ren J, Wang G, Gu G, Li G, Wu X, Chen J, Ren H, Hong Z, Wu L, Chen G, Youming D, Li J. Early Liver Dysfunction in Patients With Intra-Abdominal Infections. Medicine (Baltimore). 2015 Oct;94(42):e1782. doi: 10.1097/MD.0000000000001782.

    PubMed 26496306
  • Yang XJ, Liu D, Ren HY, Zhang XY, Zhang J, Yang XJ. Effects of sepsis and its treatment measures on intestinal flora structure in critical care patients. World J Gastroenterol. 2021 May 21;27(19):2376-2393. doi: 10.3748/wjg.v27.i19.2376.

    PubMed 34040329

Questions about this trial

What is this clinical trial studying?

An observational study of Gut Microbiota and Intra-abdominal Infections, run by Chinese Medical Association 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 5 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 28 Nov 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?

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?

mortality (time frame: Day28 after enrollment). 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 NCT05628493, 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 28 Nov 2022.

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