Critical-IllnessNOSEPPNCT02442986
Neurological Outcome in Surgical and Non-surgical Septic Patients
An observational study of Critical-Illness and Polyneuropathy, run by University of Rostock at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical-Illness, Polyneuropathy, Myopathy
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Fulfilling criteria for severe sepsis or septic shock
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Intensive Care Units PIT 1+2, University hospital Rostock
Rostock, 18055
About this study
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.
Read the 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.
- Conditions
- Critical-Illness, Polyneuropathy, Myopathy, Septic Encephalopathy
- Keywords
- weaning failure, polyneuropathy, encephalopathy, sepsis
- Medical subject headings
- Critical Illness, Polyneuropathies, Muscular Diseases, Sepsis-Associated Encephalopathy, Brain Diseases, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Septic Encephalopathy
EEG, MRT, CSF (cerebrospinal fluid)
Measured: day 7
Critical-Illness-Polyneuropathy and -myopathy
ENG
Measured: day 7
Septic Encephalopathy (28)
Clinical observation.
Measured: day 28
Critical-Illness-Polyneuropathy and -myopathy (28)
Clinical observation.
Measured: day 28
Secondary outcomes (4)
- 28-day survival (observation time 100 days)
Survival after 28 days.
Measured: day 28
- Time of respirator-therapy
In days cumulative.
Measured: 1 year
- Dosage of vasopressors (cumulative)
In days cumulative.
Measured: observation time 100 days
- 100 day survival
Survival after 100 days.
Measured: day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startNov 2012
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical-IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Martin Sauer, MD, University of Rostock
- Investigators
- Martin Sauer, MD, Study chair, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442986
- Sponsor's protocol ID
- URostock
- Acronym
- NOSEPP
- Status last verified
- Apr 2017
- First submitted
- 29 Apr 2015
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ehler J, Barrett LK, Taylor V, Groves M, Scaravilli F, Wittstock M, Kolbaske S, Grossmann A, Henschel J, Gloger M, Sharshar T, Chretien F, Gray F, Noldge-Schomburg G, Singer M, Sauer M, Petzold A. Translational evidence for two distinct patterns of neuroaxonal injury in sepsis: a longitudinal, prospective translational study. Crit Care. 2017 Oct 23;21(1):262. doi: 10.1186/s13054-017-1850-7.
PubMed 29058589
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study: Comparison of Neurological Outcome in Septic Surgical, Septic Non-surgical and Non-septic Patients on ICU
- ClinicalTrials.gov ID
- NCT02442986
- Acronym / sponsor ID
- NOSEPP / URostock
- Conditions
- Critical-Illness, Polyneuropathy, Myopathy, Septic Encephalopathy
- Keywords
- weaning failure, polyneuropathy, encephalopathy, sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Fulfilling criteria for severe sepsis or septic shock
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Septic Encephalopathy
Time frame: day 7
EEG, MRT, CSF (cerebrospinal fluid)
Critical-Illness-Polyneuropathy and -myopathy
Time frame: day 7
ENG
Septic Encephalopathy (28)
Time frame: day 28
Clinical observation.
Critical-Illness-Polyneuropathy and -myopathy (28)
Time frame: day 28
Clinical observation.
4 secondary outcomes
- 28-day survival (observation time 100 days)
Time frame: day 28
- Time of respirator-therapy
Time frame: 1 year
- Dosage of vasopressors (cumulative)
Time frame: observation time 100 days
- 100 day survival
Time frame: day 100
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Derived from this study: PubMed 29058589Ehler J, Barrett LK, Taylor V, Groves M, Scaravilli F, Wittstock M, Kolbaske S, Grossmann A, Henschel J, Gloger M, Sharshar T, Chretien F, Gray F, Noldge-Schomburg G, Singer M, Sauer M, Petzold A. Translational evidence for two distinct patterns of neuroaxonal injury in sepsis: a longitudinal, prospective translational study. Crit Care. 2017 Oct 23;21(1):262. doi: 10.1186/s13054-017-1850-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Sauer, MD study chair
University of Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical-Illness and Polyneuropathy, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Septic Encephalopathy (time frame: day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02442986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.