Interest of Plasma microRNAs

Interest of Plasma microRNAs Assay in ICU Acquired Muscle Weakness Diagnosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02464371

Acronym

µARN

Enrollment

Registered

2015-06-08

Start date

2015-05-31

Completion date

2017-05-13

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

muscle weakness, microRNAs, septic shock

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.

Interventions

OTHERkinetic of microRNAs

blood samples will be drawn to measure microRNAs

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
predictive threshold of evolution to the IAMW	Day 1	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026