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Completed

NCT Number: NCT01463995

Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)

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.

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Key information

Conditions

Neurological Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)

Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • NeuroCure Clinical Research Center, Charite, Berlin

Registry information

Acronym: proNICU

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 2, 2011
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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