Myopathy Clinical Trial
Official title:
Prospective Observational Study: Comparison of Neurological Outcome in Septic Surgical, Septic Non-surgical and Non-septic Patients on ICU
Systemic inflammation and sepsis cause multi organ failure including severe neurologic
impairment in the course of disease. Neurologic failure typically presents as
critical-illness-polyneuropathy/-myopathy and septic encephalopathy during sepsis and is
associated with an increased mortality rate.
Clinical parameters to determine the neurologic entities during the course of sepsis are
heterogeneous. Further research for an association of clinical parameters and the patients'
outcome is needed.
The study aims toward differences in the clinical and neurological outcome of surgical and
non-surgical septic patients in comparison to non-septic patients on ICU. The aim of the
study is to identify clinical and diagnostic outcome predictors in septic patients.
All patients with severe sepsis and septic shock and fulfilling the inclusion criteria
should be screened for the study on two surgical (septic surgical patients), one medical
intensive care unit (septic non-surgical patients) and one neurological intensive care unit
(non-septic patients) at the university hospital of Rostock, Germany.
The inclusion of patients will be started if written informed consent was obtained from all
participants or their representatives (if direct consent could not be obtained).
The aim of the study is to determine differences in the neurological outcome of surgical and
non-surgical septic patients (incidence, severity and length of
critical-illness-polyneuropathy/-myopathy and septic encephalopathy). The main interest of
the study is to find parameters associated with an improved neurological outcome in septic
patients within an observation time of 100 days.
The main criterion is the incidence, severity and length of septic encephalopathy and
critical-illness-polyneuropathy and -myopathy on days 7 and 28.
From all patients basic demographic data, illness severity scores (APACHE-II, SOFA) and
delirium scores for the assessment of septic encephalopathy (CAM-ICU, ICDSC), laboratory,
cerebrospinal fluid and microbiological results, electrophysiological
(electroneurography(ENG)), electroencephalography (EEG), cranial MRI results, pre-morbidity
data and clinical outcome for the study cohort will be recorded. At the days 1, 3, 7 and 28
the patients will be screened for clinical and laboratory/immunological data: hemodynamic,
inflammation, coagulation, organ function, blood parameters including cytokines.
Neurological examination and EEG will be performed within 24 hours after the beginning of
the study. Examination of liquor cerebrospinalis will be performed within 24-48 hours and
cranial MRI between day 3 and 7 after the inclusion of the patient. ENG will be done
earliest one week after the beginning of the study.
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