Status:

TERMINATED

Use of Neurostimulation As a Tool for Reconditioning the Neuromuscular System of Patients Admitted to the ICU for Septic Shock

Lead Sponsor:

Centre Hospitalier Universitaire Dijon

Conditions:

Septic Shock

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Patients hospitalized in the ICU are likely to develop sarcopenia due to a progressive and generalized decrease in muscle mass that is responsible for generalized muscle weakness known as resuscitatio...

Eligibility Criteria

Inclusion

  • Age ≥ 18 years
  • Admitted to the ICU for :
  • Sepsis as defined by the presence of an infection, of known or suspected origin + organ dysfunction with a SOFA score ≥ 2
  • Or septic shock defined by sepsis with persistent hypotension requiring vasopressors to maintain mean artérial blood pressure ≥ 65 mmHg and serum lactate level \> 2 mmol/l despite adequate vascular filling
  • After obtaining informed consent from a relative/trusted person or patient included in an emergency situation
  • Patient affiliated to national health insurance.

Exclusion

  • Patient with a contraindication to the application of ES (e.g. pacemaker, defibrillator)
  • Patient with a diagnosis of deep vein thrombosis and/or pulmonary embolism, confirmed and treated within the last 48 hours
  • Patient with cardiac arrest prior to study inclusion
  • Patient for whom a decision to limit or stop treatment has been made by the medical team
  • Patients with a very poor prognosis in the very short term due to major co-morbidities (Child Pugh score C cirrhosis, terminal cancer, neuro-evolutionary disease with no treatment plan...)
  • Patients with known neuro-orthopaedic and sensory disorders prior to inclusion, whether of originating in the spinal cord, nerve or brain.
  • Person subject to a legal protection measure (curatorship, guardianship)
  • Pregnant, parturient or breastfeeding women.
  • Secondary

Key Trial Info

Start Date :

March 25 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 11 2024

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT05257759

Start Date

March 25 2022

End Date

June 11 2024

Last Update

February 19 2025

Active Locations (1)

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1

Chu Dijon Bourgogne

Dijon, France