Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01463995
First received: October 31, 2011
Last updated: September 17, 2014
Last verified: September 2014
  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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: October 2016
Estimated Primary Completion Date: October 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Andreas Meisel, MD Charite University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
  More Information

No publications provided

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
Study First Received: October 31, 2011
Last Updated: September 17, 2014
Health Authority: Germany: Ethics Commission of the Charité University Berlin

Keywords provided by 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

ClinicalTrials.gov processed this record on November 20, 2014