Acute Intestinal Failure in Critically Ill Patients and Microbial Translocation

NCT03861325 | Completed

• 1 other identifier: 2018-A02192-53
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of the investigators is that patients with septic shock in ICU have acute intestinal insufficiency favoring subclinical microbial translocation, which is the consequence of alterations of the epithelium, and is accompanied by qualitative and quantitative changes in the gut microbiota. The primary objective is to determine the incidence of microbial translocation by measuring 16S rDNA and 18S rDNA plasma levels in a patient population with septic shock. Secondary objectives are:

• Describe the kinetics of markers of intestinal insufficiency (I-FABP / zonulin) over time (at admission, 12 hours after admission, one day, two day, three days and seven day after admission).
• Study the correlation between the titer of I-FABP, zonulin, 16srDNA, 18srDNA and the stages of acute gastrointestinal insufficiency (AGF).
• Establish correlations between the microorganisms of the intestinal microbiota and the bacteria involved in microbial translocation.
• Study the possible correlations between the 16SrDNA levels and the other bacterial markers (sCD14, LBP).
• Describe the evolution of the composition and the diversity of the gut microbiota in the first 7 days of septic shock

Conditions

Septic Shock

Keywords

acute gut failure

Outcome Measures

Primary Outcomes (1)

• Describe the incidence of microbial translocation in critical illness by measuring 16S rDNA and 18S rDNA plasma levels in a patient population with septic shock

  Plasma levels of circulating 16S rDNA and 18S rDNA will be measured at admission in ICU then 12 hours, 1 day, 2 days, 3 days and seven days later after admission.

  7 days

Secondary Outcomes (5)

• Describe the kinetics of markers of intestinal insufficiency by measuring I-FABP and Zonulin plasma levels

  7 days

• Study the correlation between the titer of I-FABP, zonulin, 16S rDNA, 18S rDNA and the stages of acute gastrointestinal insufficiency (AGF)

  7 days

• Establish correlations between the microorganisms of the intestinal microbiota and the bacteria involved in microbila translocation

  7 days

• Study the possible correlations between the 16SrDNA plasma levels and the other bacterial markers (plasma levels of sCD14, LBP)

  7 days

• Perform a qualitative and quantitative analysis of the intestinal microbiota at admission to intensive care and after 7 days from a stool sample taken on admission to intensive care on the seventh day after admission

  7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with septic shock

You may qualify if:

• The patient or his / her representative has been informed about the implementation of the study, its objectives, its constraints, the rights of the patient and must have received the newsletter and no opposition of the study.
• The patient must be an affiliate or beneficiary of a health insurance plan.
• The patient is at least 18 years old.
• The patient has septic shock as defined by the 3rd International Conference for the definition of sepsis and septic shock

You may not qualify if:

• The patient is under guardianship, under guardianship, or under the protection of justice
• The patient has already participated in this study
• The patient or his / her representative refuses to participate in the study
• The patient is pregnant, parturient or is breastfeeding
• The patient is a minor
• The patient is in therapeutic limitation or moribund
• The patient has undergone or is going to have scheduled or emergency digestive surgery
• The patient is HIV-positive
• The patient has Child C cirrhosis
• The patient has progressive digestive neoplasia, digestive lymphoma, chronic inflammatory bowel disease (Crohn's disease ...).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nimes University Hospital

Nîmes, 30029, France

Location

Related Publications (1)

• Magnan C, Lancry T, Salipante F, Trusson R, Dunyach-Remy C, Roger C, Lefrant JY, Massanet P, Lavigne JP. Role of gut microbiota and bacterial translocation in acute intestinal injury and mortality in patients admitted in ICU for septic shock. Front Cell Infect Microbiol. 2023 Dec 18;13:1330900. doi: 10.3389/fcimb.2023.1330900. eCollection 2023.

  PMID: 38179421 RESULT

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 4, 2019
• Study Start: April 2, 2019
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: December 3, 2025

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)