eurological Sequelae of Sepsis (NeuroSOS-CIP): Investigation of nerve and muscle in patients with critical illness polyneuropathy (CIP) using MRI

Recruiting

Conditions: G62.8
G72.8
G62.80
A41.9
Sepsis, unspecified
Other specified polyneuropathies
Other specified myopathies

Registration Number: DRKS00000652

Lead Sponsor: CSCC Jena (Center for Sepsis Control and Care)Hans Berger Klinik für Neurologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Patients with severe sepsis and/or septic shock according to the CSCC Criteria since =4 days.
Consent of study participation. Age = 18 years, diagnosis of CIP according to electroneurographic criteria.

Exclusion Criteria

Patient has a history of neuromuscular disorders (e.g. polyneuropathy, muscle disease, myasthenia gravis, amyotrophic lateral sclerosis, etc.), known alcohol abuse, known diabetes mellitus, high-dose steroid therapy before sepsis (=16 mg/kg body weight for 5 days), ICU stay =8 days, patient is likely to die within less than 24 hours, participation in another clinical study, contraindication for MRI (e.g. pacemaker)

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. MR parameters of nerve tissue: changes in T2-weighted sequences, diffusion weighted sequences, gadolinium-enhancement in the ischiadic nerve, the lumbosacral plexus, and the nerve roots. 2. MR parameters in the muscles: changes in T2-weighted sequences, diffusion weighted sequences, gadolinium-enhancement in the quadriceps muscle. <br>Time points of visitation are in the first week after onset of the acute sepsis and 3 to 4 weeks later.

Secondary Outcome Measures

Name	Time	Method
1. MR parameters in correlation to electrophysiological measurements (amplitudes, conduction time) (neuropathy). 2. MR parameters in correlation to muscle biopsy results (myopathy).<br>Time points of visitation are in the first week after onset of the acute sepsis and 3 to 4 weeks later.