Interest of Plasma microRNAs (µARN)

Interest of Plasma microRNAs Assay in ICU Acquired Muscle Weakness Diagnosis

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).

Study Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Other: kinetic of microRNAs

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 Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• France
  • Roanne, France, 42300
    • CH Roanne
  • Saint-etienne, France, 42055
    • CHU SAINT-ETIENNE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

septic shock patients admitted into ICU.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: kinetic of microRNAs; 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	Other: kinetic of microRNAs; blood samples will be drawn to measure microRNAs

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 3, 2017
• Study Completion (Actual): May 13, 2017

Study Registration Dates

• First Submitted: June 2, 2015
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: muscle weakness; microRNAs; septic shock
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Shock; Sepsis; Neuromuscular Manifestations; Shock, Septic; Muscle Weakness
• Other Study ID Numbers: 1508014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No