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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02192-53 | Other Identifier | ANSM |
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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:
All eligible patients admitted for septic shock in resuscitation at Nimes will be included in the study, after verification of inclusion and non-inclusion criteria and with their agreement.
This is an observational study with no impact on the quality of care provided. All study data will be entered into an electronic CRF (e-CRF) directly or from the paper version of the scorecard.
The entry into the e-CRF is controlled and formatted to prohibit the input of out-of-bounds or outliers. In case of modification of data entry, traceability and monitoring of activities is ensured. An electronic signature committing the responsibility of the investigator of each center will allow the validation of the visit and the e-CRF.
Only those persons participating in the research project and identified will have access to the software allowing this entry: Redcap.
Redcap software that allows you to generate electronic CRFs (e-CRF), electronically capture data, manage it and restore it. It also makes it possible to follow the progress of studies in terms of data entry and to manage them. It is open source software that is extensible, modular and based on international standards.
Redcap software allows:
The clinical data of the study will be stored on a specific directory of the server. Only the network administrators and the authorized persons of the clinical research unit of the medical information department can have access to this directory.
IT arrangements made to enforce the confidentiality commitment
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the kinetics of markers of intestinal insufficiency by measuring I-FABP and Zonulin plasma levels | Plasma levels of I-FABP and Zonulin will be measured at admission in ICU then 12 hours, 1 day, 2 days, 3 days and seven days later after admission. | 7 days |
| Study the correlation between the titer of I-FABP, zonulin, 16S rDNA, 18S rDNA and the stages of acute gastrointestinal insufficiency (AGF) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with septic shock
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nimes University Hospital | Nîmes | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41839701 | Result | Pansu N, Drakulovski P, Krasteva D, Bellet V, Lavigne JP, Dunyach-Remy C, Salipante F, Yahiaoui-Martinez A, Donnadieu-Rigole H, Bertout S. Detection of Fungal Translocation in Patients With Alcohol Use Disorder Using a Real-Time PCR Assay. APMIS. 2026 Mar;134(3):e70181. doi: 10.1111/apm.70181. | |
| 38179421 | Result |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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Plasma levels of 16S rDNA, 18S rDNA, I-FABP and Zonulin will be measured at admission in ICU then 12 hours, 1 day, 2 days, 3 days and seven days later after admission and stages of AGF will be evaluated at the same time. |
| 7 days |
| Establish correlations between the microorganisms of the intestinal microbiota and the bacteria involved in microbila translocation | the results of the qualitative analysis of the microbiota will be compared with the results of the classic microbiological samples taken on admission to the intensive care unit | 7 days |
| Study the possible correlations between the 16SrDNA plasma levels and the other bacterial markers (plasma levels of sCD14, LBP) | Plasma levels of 16S rDNA, sCD14 and LBP will be measured at admission in ICU then 12 hours, 1 day, 2 days, 3 days and seven days later after admission. | 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 | The metagenomic analysis of the gut microbiota is based on the high-throughput sequencing of all bacteria in a stool sample by targeting the 16S rRNA genes. The first step of this technique is to PCR amplify a 16S rDNA genomic target (eg V3-V4 regions) from stool sample DNA and to control the amplified sequences (called "libraries"). The second step consists in sequencing the libraries on a sequencing automaton. The bioinformatic analysis of the sequences consists of making a reference sequence library of the 16S rDNA target and aligning the sequences obtained with this database in order to establish lists of present organisms and taxonomic trees (OTU - operational taxonomic unit). | 7 days |
| 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. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |