A41.9 G62.8
Conditions
Interventions
Group 1: No intervention, but diagnostic procedures of patients with sepsis: skin biopsies, electroneurographic measurements, and clinical neurological status at 3 time points: 4 days after begin of s
Sponsors
CSCC Jena (Center for Sepsis Control and Care)
Hans Berger Klinik für Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with sepsis: patients with severe sepsis and/or septic shock according to the CSCC Criteria since =4 days. Consent of study participation. Age = 18 years. Healthy control group: Consent of study participation. Age = 18 years.
Exclusion criteria
Exclusion criteria: Patients with sepsis: Patient has a history of neuromuscular disorders, known alcohol abuse, 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, thrombozytes60, INR>1.7; healthy controls: history of neuromuscular disorders, oral anticoagulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IENF per mm: Nerve densities of somatic intraepidermal nerve fibres in skin biopsies in the course sepsis (acute phase, 2 weeks later, after 4 months). The measuremnets will be done only once in the healthy control group. Intraepidermal nerve fibre density is determined in histological stainings (PGP 9.5, thickness 50 µm) of the skin biopsies. The nerve fibres crossing the epidermal basal lamina are counted (related to length of the analyzed skin). | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraepidermal nerve fiber density in correlation to electrophysiological measurements, in correlation to clinical parameters, and in correlation to critical illness polyneuropathy, at the three time points (acute phase of sepsis, 2 weeks later, after 4 months). The measurements will be done only once in the healthy control group. | — |
Countries
Germany
Contacts
Public ContactHubertus Axer
CSCC Jena (Center for Sepsis Control and Care) Hans Berger Klinik für Neurologie
Outcome results
None listed