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Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort) (proNICU)

This study is currently recruiting participants.
Verified June 2017 by Andreas Meisel, Charite University, Berlin, Germany
Sponsor:
ClinicalTrials.gov Identifier:
NCT01463995
First Posted: November 2, 2011
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
NeuroCure Clinical Research Center, Charite, Berlin
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany
  Purpose
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.

Condition
Neurological Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)

Resource links provided by NLM:


Further study details as provided by Andreas Meisel, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset [ Time Frame: one year after symptom onset ]
    To evaluate of the predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset


Secondary Outcome Measures:
  • 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

  • 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

  • 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 ]
    To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset

  • Transcriptome analyses [ Time Frame: one year after symptom onset ]
    To perform transcriptome analyses to identify new biomarkers which may predict the one year- neurological outcome

  • 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

  • Quality of life and occurence of depression in patients one year after symptom onset [ Time Frame: one year after symptom onset ]
    To investigate the quality of life and the occurence of depression in patients one year after symptom onset

  • Quality of life and the occurence of depression and burnout syndrome in relatives [ Time Frame: one year after symptom onset ]
    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


Biospecimen Retention:   Samples With DNA
Blood samples (serum, plasma), cerebrovascular fluid

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
severe neurological diseases
Patients with severe neurological diseases treated on the neurological intensive care unit

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with severe neurological diseases treated on a neurological intensive care unit
Criteria

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
  Contacts and Locations
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): NCT01463995


Contacts
Contact: Andreas Meisel, MD +49 30 450 ext 560026 andreas.meisel@charite.de

Locations
Germany
Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC) Recruiting
Berlin, Germany
Contact: Lena Ulm, MD    +49 30 450 ext 639726    lena.ulm@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
NeuroCure Clinical Research Center, Charite, Berlin
Investigators
Principal Investigator: Andreas Meisel, MD Charite University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
  More Information

Responsible Party: Andreas Meisel, Prof. Dr. med. Andreas Meisel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01463995     History of Changes
Other Study ID Numbers: proNICU cohort
First Submitted: October 31, 2011
First Posted: November 2, 2011
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by Andreas Meisel, Charite University, Berlin, Germany:
severe neurological diseases
neurological intensive care unit
prediction
long-term outcome
biomarkers
prediction of long-term outcome

Additional relevant MeSH terms:
Nervous System Diseases