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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00000652
Enrollment
100
Registered
2010-12-28
Start date
2011-04-08
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A41.9 G62.8 G72.8 G62.80

Interventions

Group 1: no intervention, diagnostic procedures: screening: electroneurographic measurements. visit 1 (1 week after begin of the acute sepsis): MRI of pelvis and thigh, neurological examination, optio

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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. Time points of visitation are in the first week after onset of the acute sepsis and 3 to 4 weeks later.

Secondary

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

Countries

Germany

Contacts

Public ContactHubertus Axer

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

hubertus.axer@med.uni-jena.de+49 3641 9323454

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026