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

April 19, 2017 updated by: Dr. Martin Sauer, MD, University of Rostock

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Rostock, Germany, 18055
        • Intensive Care Units PIT 1+2, University hospital Rostock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Septic Encephalopathy
Time Frame: day 7
EEG, MRT, CSF (cerebrospinal fluid)
day 7
Critical-Illness-Polyneuropathy and -myopathy
Time Frame: day 7
ENG
day 7
Septic Encephalopathy (28)
Time Frame: day 28
Clinical observation.
day 28
Critical-Illness-Polyneuropathy and -myopathy (28)
Time Frame: day 28
Clinical observation.
day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- 28-day survival (observation time 100 days)
Time Frame: day 28
Survival after 28 days.
day 28
- Time of respirator-therapy
Time Frame: 1 year
In days cumulative.
1 year
- Dosage of vasopressors (cumulative)
Time Frame: observation time 100 days
In days cumulative.
observation time 100 days
- 100 day survival
Time Frame: day 100
Survival after 100 days.
day 100

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Investigators

  • Study Chair: Martin Sauer, MD, University of Rostock

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

April 29, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URostock

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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