NOSEPP: Neurological Outcome in Surgical and Non-surgical Septic Patients

Sponsor

University of Rostock (Other)

Overall Status

Completed

CT.gov ID

NCT02442986

Collaborator

(none)

Enrollment

Location

51.9

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Critical-Illness Polyneuropathy Myopathy Septic Encephalopathy

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

32 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Prospective Observational Study: Comparison of Neurological Outcome in Septic Surgical, Septic Non-surgical and Non-septic Patients on ICU

Actual Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Septic Shock or severe sepsis Septic patients on ICU with severe sepsis or septic shock.
Non-Septic, Surgical Patients Non-septic patients after surgical treatment and anesthesia on ICU.
Non-Septic, Non-Surgical Patients Patients without sepsis criteria treated on ICU, non-surgical patients.

Outcome Measures

Primary Outcome Measures

Septic Encephalopathy [day 7]
EEG, MRT, CSF (cerebrospinal fluid)
Critical-Illness-Polyneuropathy and -myopathy [day 7]
ENG
Septic Encephalopathy (28) [day 28]
Clinical observation.
Critical-Illness-Polyneuropathy and -myopathy (28) [day 28]
Clinical observation.

Secondary Outcome Measures

- 28-day survival (observation time 100 days) [day 28]
Survival after 28 days.
- Time of respirator-therapy [1 year]
In days cumulative.
- Dosage of vasopressors (cumulative) [observation time 100 days]
In days cumulative.
- 100 day survival [day 100]
Survival after 100 days.