NCT02464371

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2017

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2017

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

June 2, 2015

Last Update Submit

May 15, 2017

Conditions

Septic Shock

Keywords

muscle weaknessmicroRNAsseptic shock

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • predictive threshold of evolution to the IAMW

    Day 1

  • predictive threshold of evolution to the IAMW

    Day 3

  • predictive threshold of evolution to the IAMW

    Day 5

  • predictive threshold of evolution to the IAMW

    Day 7

Study Arms (2)

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

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

Interventions

kinetic of microRNAsOTHER

blood samples will be drawn to measure microRNAs

ICU acquired muscle weakness (IAMW) group +ICU acquired muscle weakness (IAMW) group -

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

septic shock patients admitted into ICU.

You may qualify if:

  • 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

You may not qualify if:

  • Age\<18years
  • Patients with preexisting neuromuscular disease
  • Pregnancy
  • Moribund patients with early therapeutic limitation
  • Patients who had a seizure in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ch Roanne

Roanne, 42300, France

Location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be drawn to compare the kinetics of microRNAs (miR-1, miR-21, miR-133, miR-155, miR-206, miR-208a, miR-208b, miR-486, miR-499).

MeSH Terms

Conditions

Shock, SepticMuscle Weakness

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Jerome MOREL, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2015

First Posted

June 8, 2015

Study Start

May 1, 2015

Primary Completion

May 3, 2017

Study Completion

May 13, 2017

Last Updated

May 16, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)