Proteomic Profiling to Reveal Novel Prognostic Markers for Neurological Outcome Following Resuscitation

NCT01960699 | Completed

• 1 other identifier: EK_Nr_1740/2013
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Cardiac arrest is a life-threatening event. Intensivists are challenged with an increasing number of patients with uncertain neurological outcome following cardiopulmonary resuscitation (CPR). The prognostic value of current biomarkers for neurophysiologic long-term outcome is limited. Hypothesis: We hypothesize that specific brain-derived tissue leakage proteins can be identified to reveal novel, more reliable prognostic biomarkers for good neurological outcome. Methods: This translational study (n=100) is a combination of a prospective basic science study intended to reduce the number of potential plasma biomarker candidates by proteomic shotgun analyses in brain tissue autopsy samples and plasma samples from resuscitated patients (n=10) and a prospective clinical validation study in a large study population (n=90) by high-throughput analyses. Selection of proteomic markers and signature estimation will be performed to discriminate patients with good and poor outcome. Clinical perspective: A structured proteomic analysis approach might identify the best marker out of all proteins liberated during cellular damage.

Conditions

Cardiac Arrest With Successful Resuscitation

Keywords

Prognosis; Neurological outcome; Resuscitation; Biomarker

Outcome Measures

Primary Outcomes (1)

• Cerebral performance categories (CPC)of <3

  participants will be followed for the duration of intensive-care unit stay, an expected average of 2 weeks.

Secondary Outcomes (1)

• Cerebral performance categories (CPC)of <3

  6 Months

Other Outcomes (2)

• Brain glucose metabolism

  Day 1 after end of cooling period

• Clinical outcome (rehospitalization and death)

  3 years

Study Arms (2)

CPC < 3

Good neurological outcome

CPC >/= 3

Unvavourable neurologic outcome

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Resuscitated patients

You may qualify if:

• Nontraumatic, normothermic cardiac arrest due to cardiac disorders, respiratory failures, or hemodynamic or metabolic factors.
• A Glasgow Coma Scale of 3, none of the patients will be conscious at the time of hospital admission.
• No previous cardiac arrest, as well as known or coexisting neurological disorders or neoplasms of the central nervous system.
• No history of psychiatric illness, no alcohol or drug dependency, and no psychotropic medication.
• Initiation of mild therapeutic hypothermia

You may not qualify if:

• hydrocephalus and shunt artifact
• severe movement artifacts
• intracerebral hemorrhage
• old large ischemic lesion

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Distelmaier K, Muqaku B, Wurm R, Arfsten H, Seidel S, Kovacs GG, Mayer RL, Szekeres T, Wallisch C, Hubner P, Goliasch G, Heinze G, Heinz G, Sterz F, Gerner C, Adlbrecht C. Proteomics-Enriched Prediction Model for Poor Neurologic Outcome in Cardiac Arrest Survivors. Crit Care Med. 2020 Feb;48(2):167-175. doi: 10.1097/CCM.0000000000004105.

  PMID: 31939784 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples stored at -80°C

Study Officials

• Christopher Adlbrecht, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 11, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

AU (1)