Interest of Plasma microRNAs

NCT ID: NCT02464371

Last Updated: 2017-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-05-13

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.

Conditions

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Septic Shock

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ICU acquired muscle weakness (IAMW) group +

The Medical Research Council score (MRC score) is lower than 48, defining an ICU acquired muscle weakness (IAMW).

Kinetic of microRNAs is measured

kinetic of microRNAs

Intervention Type OTHER

blood samples will be drawn to measure microRNAs

ICU acquired muscle weakness (IAMW) group -

The Medical Research Council score (MRC score) is higher than 48. Kinetic of microRNAs is measured

kinetic of microRNAs

Intervention Type OTHER

blood samples will be drawn to measure microRNAs

Interventions

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kinetic of microRNAs

blood samples will be drawn to measure microRNAs

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jerome MOREL, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Ch Roanne

Roanne, , France

Site Status

Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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1508014

Identifier Type: -

Identifier Source: org_study_id

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