- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01463995
Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort) (proNICU)
November 28, 2018 updated by: Andreas Meisel, Charite University, Berlin, Germany
This study examines the prognostic properties of immune parameters, clinical scores, electrophysiological tests (eeg, ssep, emg, eng) and functional imaging for the prediction of functional outcome one year after treatment on a neurological intensive care unit.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
46
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
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Berlin, Germany
- Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
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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
patients with severe neurological diseases treated on a neurological intensive care unit
Description
Inclusion Criteria:
- severe neurological disease making treatment on a neurological intensive care unit necessary
- age ≥ 18
- consent by the patient or the legal representative
Exclusion Criteria:
- participation in an interventional trial
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 |
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severe neurological diseases
Patients with severe neurological diseases treated on the neurological intensive care unit
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset
Time Frame: one year after symptom onset
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To evaluate of the predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset
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one year after symptom onset
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate of the predictive properties of clinical scores for functional outcome one year after symptom onset
Time Frame: one year after symptom onset
|
To evaluate of the predictive properties of clinical scores for functional outcome one year after symptom onset
|
one year after symptom onset
|
To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset
Time Frame: one year after symptom onset
|
To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset
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one year after symptom onset
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To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset
Time Frame: one year after symptom onset
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To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset
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one year after symptom onset
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Transcriptome analyses
Time Frame: one year after symptom onset
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To perform transcriptome analyses to identify new biomarkers which may predict the one year- neurological outcome
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one year after symptom onset
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Predictive properties of immune parameters in the cerebrovascular fluid for functional outcome one year after symptom onset
Time Frame: one year after symptom onset
|
To evaluate of the predictive properties of immune parameters in the cerebrovascular fluid for functional outcome one year after symptom onset
|
one year after symptom onset
|
Quality of life and occurence of depression in patients one year after symptom onset
Time Frame: one year after symptom onset
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To investigate the quality of life and the occurence of depression in patients one year after symptom onset
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one year after symptom onset
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Quality of life and the occurence of depression and burnout syndrome in relatives
Time Frame: one year after symptom onset
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To investigate the quality of life and the occurence of depression and burnout syndrome in relatives of patients treated on the neurological intensive care unit one year after symptom onset
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one year after symptom onset
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
June 1, 2012
Primary Completion (Actual)
October 3, 2016
Study Completion (Actual)
October 3, 2016
Study Registration Dates
First Submitted
October 31, 2011
First Submitted That Met QC Criteria
November 1, 2011
First Posted (Estimate)
November 2, 2011
Study Record Updates
Last Update Posted (Actual)
November 29, 2018
Last Update Submitted That Met QC Criteria
November 28, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- proNICU cohort
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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