Interest of Plasma microRNAs

Septic Shock Clinical Trial

— µARN  

Official title:

Interest of Plasma microRNAs Assay in ICU Acquired Muscle Weakness Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464371
• Other study ID #: 1508014
• Status: Completed
• Phase: N/A
• First received: June 2, 2015
• Last updated: May 15, 2017
• Start date: May 2015
• Est. completion date: May 13, 2017

Study information

• Verified date: May 2017
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 13, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Septic Shock
• Shock, Septic

Intervention

Other:
• kinetic of microRNAs
blood samples will be drawn to measure microRNAs

Locations

Country	Name	City	State
France	Ch Roanne	Roanne
France	Chu Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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