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临床试验/NCT02464371
NCT02464371已完成不适用

Interest of Plasma microRNAs Assay in ICU Acquired Muscle Weakness Diagnosis

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
2
主要终点
Values of microRNAs between day 1 and day 7

研究概览

简要总结

ICU acquired muscle weakness (IAMW) is a common disease that is associated with high morbidity and mortality. Patients with septic shock are particularly at risk.

The diagnosis of IAMW is clinical and based on the rating of the Medical Research Council score (MRC score). A MRC score lower than 48 defines the IAMW. But this evaluation is only usable in sufficiently awaken patients.

Several studies have highlighted the role of microRNAs in regulating physiological processes and diseases related to the skeletal muscles. To date, no study was interested in IAMW.

The aim of this study is to compare the microRNA detection kinetics on the appearance of IAMW.

In septic shock patients, the kinetics of nine microRNAs will be compared between two groups: those with IAMW (IAMW + group) and those without IAMW (IAMW - group).

详细描述

MicroRNAs (miR-1, miR-21, miR-133, miR-155, miR-206, miR-208a, miR-208b, miR-486, miR-499) will be measured at day 1, day 2, day 5 and day 7 after septic shock onset.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Patients with septic shock criteria:
  • At least two of the following criteria: temperature < 36 ° C or > 38 ° C, heart rate > 90 beats / minute, respiratory rate> 20 breaths / minute or PaCO2 < 32mmHg, leukocytes > 12,000 / mm3 or < 4000 / mm3
  • Refractory Hypotension (blood pressure < 90mmHg or need norepinephrine) or lactate ≥ 4 mmol / L

排除标准

  • Age<18years
  • Patients with preexisting neuromuscular disease
  • Pregnancy
  • Moribund patients with early therapeutic limitation
  • Patients who had a seizure in the last 6 months

结局指标

主要结局

Values of microRNAs between day 1 and day 7

时间窗: Day 7

Values of microRNAs measured between day 1 and day 7 in the 2 groups (IAMW+ group and IAMW- group).

次要结局

  • predictive threshold of evolution to the IAMW(Day 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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