eurological Sequelae of Sepsis: Investigation of impairment of small somatic and autonomic nerve fibres in patients with sepsis

Recruiting

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

Registration Number: DRKS00000642

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: 200

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

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, thrombozytes<40, PTT>60, INR>1.7;
healthy controls: history of neuromuscular disorders, oral anticoagulation.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.