Acute Intestinal Failure in Critically Ill Patients and Microbial Translocation (NCT03861325) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ...).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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