Out-Of-Hospital Cardiac ArrestFITT-OHCANCT06299969
Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest
An observational study of Out-Of-Hospital Cardiac Arrest, run by St.Bernward Hospital at 1 site in Germany.
Trial summary
The trial collects and analyzes data from Cardiac Arrest Centres in patients with out-of-hospital cardiac arrest (OHCA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2023to 31 Dec 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 treated after out-of-hospital cardiac arrest
Who may be able to join
- Patients after cardiac arrest
Who cannot join
- refused register participation by patient or legal representative
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
St Bernward Hospital
Hildesheim, Lower Saxony, 31134
Karl H Scholz, MD, +4955139 ext. 64940, k.scholz@fitt-stemi.de
Sebastian Riedel, +4955139 ext. 64940, s.riedel@bernward-khs.de
About this study
Official title: Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest (FITT-OHCA)
The trial collects and analyzes data from Cardiac Arrest Centres in patients with out-of-hospital cardiac arrest (OHCA).
Read the detailed description
With around 70,000 cases per year, out-of-hospital cardiac arrest (OHCA) is one of the most common causes of death in Germany. Only less than 10% of patients with an OHCA can currently be discharged with a satisfactory neurological outcome. The FITT-OHCA trial is a quality management project and collects data from Cardiac Arrest Centres on pre-hospital care and early post-resuscitation treatment in a standardized manner. The aim is to optimize the treatment process in patients following successful prehospital resuscitation through systematic data collection and feedback to the members of the rescue and treatment chain. The study includes cluster randomization of the participating hospitals.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- OHCA, Out-of-hospital cardiac arrest, In-hospital cardiac arrest, Resuscitation, Cardiac arrest center, Feedback intervention, Acute care medicine
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Death/Survival at discharge
Measured: 3 weeks
Secondary outcomes (2)
CPC score
Cerebral performance category
Measured: 3 weeks
MRS
Modified ranking scale
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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 only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- St.Bernward Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Goettingen
- Responsible party
- Principal investigator, Karl Heinrich Scholz, St.Bernward Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299969
- Sponsor's protocol ID
- StBernwardH
- Acronym
- FITT-OHCA
- Status last verified
- Mar 2024
- First submitted
- 29 Dec 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest (FITT-OHCA)
- ClinicalTrials.gov ID
- NCT06299969
- Acronym / sponsor ID
- FITT-OHCA / StBernwardH
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- OHCA, Out-of-hospital cardiac arrest, In-hospital cardiac arrest, Resuscitation, Cardiac arrest center, Feedback intervention, Acute care medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- St.Bernward HospitalUniversity, hospital or other
- Collaborators
- University Medical Center Goettingen
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Mar 2024 (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.
The trial collects and analyzes data from Cardiac Arrest Centres in patients with out-of-hospital cardiac arrest (OHCA).
Detailed description
With around 70,000 cases per year, out-of-hospital cardiac arrest (OHCA) is one of the most common causes of death in Germany. Only less than 10% of patients with an OHCA can currently be discharged with a satisfactory neurological outcome. The FITT-OHCA trial is a quality management project and collects data from Cardiac Arrest Centres on pre-hospital care and early post-resuscitation treatment in a standardized manner. The aim is to optimize the treatment process in patients following successful prehospital resuscitation through systematic data collection and feedback to the members of the rescue and treatment chain. The study includes cluster randomization of the participating hospitals.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated after out-of-hospital cardiac arrest
Key inclusion criteria (1 listed)
- Patients after cardiac arrest
Key exclusion criteria (1 listed)
- refused register participation by patient or legal representative
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
In-hospital mortality
Time frame: 3 weeks
Death/Survival at discharge
2 secondary outcomes
CPC score
Time frame: 3 weeks
MRS
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Out-Of-Hospital Cardiac Arrest
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
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
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. This study is not recruiting at the moment.
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, run by St.Bernward Hospital at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl H Scholz, MD (+4955139 ext. 64940, k.scholz@fitt-stemi.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: 3 weeks). 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 8 Mar 2024.