Interest of Plasma microRNAs

Completed

• Conditions: Septic Shock
• Interventions: Other: kinetic of microRNAs

• Registration Number: NCT02464371
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-08
• Status Verified: 2017-05
• Primary Completion: 2017-05-03
• Study Completion: 2017-05-13
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU acquired muscle weakness (IAMW) group -	kinetic of microRNAs	The Medical Research Council score (MRC score) is higher than 48. Kinetic of microRNAs is measured
ICU acquired muscle weakness (IAMW) group +	kinetic of microRNAs	The Medical Research Council score (MRC score) is lower than 48, defining an ICU acquired muscle weakness (IAMW). Kinetic of microRNAs is measured

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
predictive threshold of evolution to the IAMW	Day 7	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.

Trial Locations

Locations (2)

Chu Saint-Etienne; 🇫🇷 Saint-etienne, France

Ch Roanne; 🇫🇷 Roanne, France