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

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: Neurological Diseases

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

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	To evaluate of the predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset	one year after symptom onset

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	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	To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset	one year after symptom onset
To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset	To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset	one year after symptom onset
Transcriptome analyses	To perform transcriptome analyses to identify new biomarkers which may predict the one year- neurological outcome	one year after symptom onset
Predictive properties of immune parameters in the cerebrovascular fluid for functional outcome 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	To investigate the quality of life and the occurence of depression in patients one year after symptom onset	one year after symptom onset
Quality of life and the occurence of depression and burnout syndrome in relatives	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	one year after symptom onset

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: NeuroCure Clinical Research Center, Charite, Berlin

Study record dates

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: biomarkers; prediction; long-term outcome; neurological intensive care unit; severe neurological diseases; prediction of long-term outcome
• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: proNICU cohort