Out-Of-Hospital Cardiac ArrestNCT05218278
NFL Dynamics as a Predictor Factor in Patients With Out of Hospital Cardiac Arrest
An observational study of Out-Of-Hospital Cardiac Arrest and Neurological Injury, run by University Medical Centre Maribor at 1 site in Slovenia.
Trial summary
To investigate the pharmacodynamics of light chain of NFL in patients with out-of hospital cardiac arrest after successful resuscitation and determine the difference in the serum levels of NFL in patients with favorable neurological outcome compared to those with non-favorable neurological outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Neurological Injury
- How many people
- 60 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-traumatic out-of-hospital cardiac arrest successfully resuscitated and admitted to the ICU.
Who may be able to join
- out-of-hospital cardiac arrest successfully resuscitated and admitted to the ICU
Who cannot join
- trauma, drowning, electrocution, less than 18 years of age,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University medical center Maribor
Maribor, 2000
Andrej Markota, MD, PhD, +38523212849, andrejmarkota@gmail.com
About this study
Official title: Dynamics of Light Chain of NFL as a Predictor Factor of Neurological Outcome in Patients With Out of Hospital Cardiac Arrest
To investigate the pharmacodynamics of light chain of NFL in patients with out-of hospital cardiac arrest after successful resuscitation and determine the difference in the serum levels of NFL in patients with favorable neurological outcome compared to those with non-favorable neurological outcome.
Read the detailed description
To investigate the serum levels of the light chain of NFL at different time points after ICU admission (12, 24, 30, 36, 42, 48 hours after ICU admission) patients with out-of hospital cardiac arrest after successful resuscitation and determine the difference in the serum levels of NFL in patients with favorable neurological outcome compared to those with non-favorable neurological outcome.
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with favorable neurlogical outcome | CPC 1/2 | |
| Patients with non-favorable neurological outcome | CPC3-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the dynamics of serum NFL levels measurements in patients with favorable neurological outcome compared to patients with non-favorable neurological outcome
NFL levels
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Strnad, University Medical Centre Maribor
- Investigators
- Matej Strnad, MD, PhD, Principal investigator, University medical cenetr Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218278
- Sponsor's protocol ID
- IRP-2021/01-01
- Status last verified
- Mar 2025
- First submitted
- 17 Jan 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamics of Light Chain of NFL as a Predictor Factor of Neurological Outcome in Patients With Out of Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05218278
- Acronym / sponsor ID
- IRP-2021/01-01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the pharmacodynamics of light chain of NFL in patients with out-of hospital cardiac arrest after successful resuscitation and determine the difference in the serum levels of NFL in patients with favorable neurological outcome compared to those with non-favorable neurological outcome.
Detailed description
To investigate the serum levels of the light chain of NFL at different time points after ICU admission (12, 24, 30, 36, 42, 48 hours after ICU admission) patients with out-of hospital cardiac arrest after successful resuscitation and determine the difference in the serum levels of NFL in patients with favorable neurological outcome compared to those with non-favorable neurological outcome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with favorable neurlogical outcome | – | –CPC 1/2 |
| Patients with non-favorable neurological outcome | – | –CPC3-5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-traumatic out-of-hospital cardiac arrest successfully resuscitated and admitted to the ICU.
Key inclusion criteria (1 listed)
- out-of-hospital cardiac arrest successfully resuscitated and admitted to the ICU
Key exclusion criteria (1 listed)
- trauma, drowning, electrocution, less than 18 years of age,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The difference in the dynamics of serum NFL levels measurements in patients with favorable neurological outcome compared to patients with non-favorable neurological outcome
Time frame: 3 years
NFL levels
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Undecided. IPD that underlie results in a publication
Related trials for Out-Of-Hospital Cardiac Arrest
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matej Strnad, MD, PhD principal investigator
University medical cenetr Maribor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest and Neurological Injury, run by University Medical Centre Maribor at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matej Strnad, MD, PhD (+38651225448, strnad.matej78@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the dynamics of serum NFL levels measurements in patients with favorable neurological outcome compared to patients with non-favorable neurological outcome (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.