Insuffisance Gastro-intestinale Aiguë Translocation Microbienne Chez Les Patients en Choc Septique : Une étude Pilote
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 ...).
结局指标
主要结局
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
时间窗: 7 days
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.
次要结局
- Study the possible correlations between the 16SrDNA plasma levels and the other bacterial markers (plasma levels of sCD14, LBP)(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)
- Describe the kinetics of markers of intestinal insufficiency by measuring I-FABP and Zonulin plasma levels(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)