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

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ClinicalTrials.gov Identifier: NCT01463995
Recruitment Status : Recruiting
First Posted : November 2, 2011
Last Update Posted : February 2, 2018
Sponsor:
Collaborator:
NeuroCure Clinical Research Center, Charite, Berlin
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany

Brief Summary:
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 or disease
Neurological Diseases

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)
Study Start Date : June 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
severe neurological diseases
Patients with severe neurological diseases treated on the neurological intensive care unit



Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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


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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

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)

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 Posted: November 2, 2011    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018

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