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Completed

NCT Number: NCT02464371

Interest of Plasma microRNAs

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).

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Key information

Conditions

Septic Shock Infections Inflammation Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ch Roanne, Roanne, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

kinetic of microRNAs

Other

blood samples will be drawn to measure microRNAs

Primary outcomes

  1. Values of microRNAs between day 1 and day 7

    Time frame: Day 7

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

Secondary outcomes

  1. predictive threshold of evolution to the IAMW

    Time frame: 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.

  2. predictive threshold of evolution to the IAMW

    Time frame: Day 3

    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.

  3. predictive threshold of evolution to the IAMW

    Time frame: Day 5

    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.

  4. predictive threshold of evolution to the IAMW

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Interest of Plasma microRNAs Assay in ICU Acquired Muscle Weakness Diagnosis

Acronym: µARN

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2015
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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