Interest of Plasma microRNAs

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Interest of Plasma microRNAs Assay in ICU Acquired Muscle Weakness Diagnosis

Conditions
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Septic Shock

Intervention / Treatment
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* Other: kinetic of microRNAs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Age<18years Patients with preexisting neuromuscular disease Pregnancy Moribund patients with early therapeutic limitation Patients who had a seizure in the last 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU acquired muscle weakness (IAMW) group +<br>The Medical Research Council score (MRC score) is lower than 48, defining an ICU acquired muscle weakness (IAMW). Kinetic of microRNAs is measured | Other: kinetic of microRNAs<br>* blood samples will be drawn to measure microRNAs<br>|
| ICU acquired muscle weakness (IAMW) group -<br>The Medical Research Council score (MRC score) is higher than 48. Kinetic of microRNAs is measured | Other: kinetic of microRNAs<br>* blood samples will be drawn to measure microRNAs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Values of microRNAs between day 1 and day 7 | Values of microRNAs measured between day 1 and day 7 in the 2 groups (IAMW+ group and IAMW- group). | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictive threshold of evolution to the IAMW | From the values of each microRNAs measured at D1, D3, D5 and D7, a predictive threshold of evolution to the IAMW will be sought by the analysis of a ROC curve. The kinetics of microRNAs will be compared between survivors and non-survivors at the discharge. | Day 1 | 
| predictive threshold of evolution to the IAMW | From the values of each microRNAs measured at D1, D3, D5 and D7, a predictive threshold of evolution to the IAMW will be sought by the analysis of a ROC curve. The kinetics of microRNAs will be compared between survivors and non-survivors at the discharge. | Day 3 | 
| predictive threshold of evolution to the IAMW | From the values of each microRNAs measured at D1, D3, D5 and D7, a predictive threshold of evolution to the IAMW will be sought by the analysis of a ROC curve. The kinetics of microRNAs will be compared between survivors and non-survivors at the discharge. | Day 5 | 
| predictive threshold of evolution to the IAMW | From the values of each microRNAs measured at D1, D3, D5 and D7, a predictive threshold of evolution to the IAMW will be sought by the analysis of a ROC curve. The kinetics of microRNAs will be compared between survivors and non-survivors at the discharge. | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle weakness, microRNAs, septic shock