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Neurological Outcome in Surgical and Non-surgical Septic Patients (NOSEPP)

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ClinicalTrials.gov Identifier: NCT02442986
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Martin Sauer, MD, University of Rostock

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
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 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 : November 2012
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort
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.



Primary Outcome Measures :
  1. Septic Encephalopathy [ Time Frame: day 7 ]
    EEG, MRT, CSF (cerebrospinal fluid)

  2. Critical-Illness-Polyneuropathy and -myopathy [ Time Frame: day 7 ]
    ENG

  3. Septic Encephalopathy (28) [ Time Frame: day 28 ]
    Clinical observation.

  4. Critical-Illness-Polyneuropathy and -myopathy (28) [ Time Frame: day 28 ]
    Clinical observation.


Secondary Outcome Measures :
  1. - 28-day survival (observation time 100 days) [ Time Frame: day 28 ]
    Survival after 28 days.

  2. - Time of respirator-therapy [ Time Frame: 1 year ]
    In days cumulative.

  3. - Dosage of vasopressors (cumulative) [ Time Frame: observation time 100 days ]
    In days cumulative.

  4. - 100 day survival [ Time Frame: day 100 ]
    Survival after 100 days.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Fulfilling criteria for severe sepsis or septic shock

Exclusion Criteria:

  • Diagnosis of cerebrovascular disease (pre-existing)
  • Advanced dementia
  • Diagnosis of pre-existing other neuromuscular disease
  • High-dose glucocorticosteroid therapy (> 300 mg Hydrocortisone/die)
  • Pre-existing renal replacement therapy
  • Coagulation disorder with bleeding
  • Frequent administration of neuromuscular blocking agents (> 3 times/week)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442986


Locations
Germany
Intensive Care Units PIT 1+2, University hospital Rostock
Rostock, Germany, 18055
Sponsors and Collaborators
University of Rostock
Investigators
Study Chair: Martin Sauer, MD University of Rostock

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Martin Sauer, MD, MD, University of Rostock
ClinicalTrials.gov Identifier: NCT02442986     History of Changes
Other Study ID Numbers: URostock
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Dr. Martin Sauer, MD, University of Rostock:
weaning failure
polyneuropathy
encephalopathy
sepsis

Additional relevant MeSH terms:
Brain Diseases
Critical Illness
Polyneuropathies
Sepsis-Associated Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Disease Attributes
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases