CompletedNot Applicable

Acute Intestinal Failure in Critically Ill Patients and Microbial Translocation

France60 participantsStarted 2019-04-02

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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 Exclusion Criteria: * The patient is in an exclusion period determined by a previous study * 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 ...).

What they're measuring

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

Timeframe: 7 days

Trial details

NCT IDNCT03861325

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-09-09