Cardiac ArrestHETOCANCT03172468
Definition of Hemodynamic Thresholds in Out-of-Hospital Cardiac Arrest
An observational study of Cardiac Arrest, run by Medical University of Graz at 1 site in Austria.
Trial summary
This study seeks to evaluate, whether patients suffering from cardiac arrest, that can be successfully resuscitated, can be differentiated from those, that cannot be resuscitated, using arterial blood pressure values. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- 7 Jun 2017to 31 Mar 2021
- 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: Adult patients suffering from cardiac arrest on arrival of the physician response unit are to be included, if ALS is deemed reasonable by the emergency physician. The groups to be compared are survivors (patients with sustained return of spontaneous circulation (ROSC) in the field who are transported to a hospital alive) and non-survivors (patients in whom CPR is terminated in the field).
Who may be able to join
- Out-of-hospital cardiac arrest
- Age >18 years
- Advanced Life Support started
- Arterial line placement possible
Who cannot join
- Obvious signs of death
- Advanced Directives / Do Not Attempt Resuscitation Order
- Cardiac arrest of traumatic etiology
- Documented patient refusal in advance
Trial locations and contacts
1 site in 1 country.
Austria1 site
Prehospital Physician Response System, Medical University of Graz
Graz, Styria, 8036
About this study
Official title: Definition of Hemodynamic Thresholds in Out-of-Hospital Cardiac Arrest: Advancing Advanced Life Support Towards Goal Directed Resuscitation
This study seeks to evaluate, whether patients suffering from cardiac arrest, that can be successfully resuscitated, can be differentiated from those, that cannot be resuscitated, using arterial blood pressure values.
Read the detailed description
Cardiopulmonary resuscitation (CPR) in patients suffering from cardiac arrest out of hospitals is based on strict clinical practice guidelines. However, the evidence base for these treatment recommendation is insufficient in many respects. While knowledge about basic interventions, that are capable of restoring spontaneous circulation and improving neurologically intact survival - chest compressions, application of oxygen and early defibrillation -, has increased over the last decade, advanced treatment options - advanced airway management, vascular access, application of vasoactive drugs - are still recommended, although clinical trials of varying quality failed to demonstrate any benefit in patient related outcomes.
This study seeks to establish hemodynamic threshold values that are able to discriminate between patients that achieve return of spontaneous circulation (survivors) and those that fail to do so (non-survivors). These cutoff values could act as targets for interventions during CPR (i.e. application of vasoactive drugs, use of mechanical compression devices, …) in further trials and may potentially influence clinical practice later on. Furthermore, reliable cutoff values could act as additional prognostic factors during CPR, enabling prehospital care providers to base their decisions to continue or terminate ongoing CPR efforts on a more solid basis.
To achieve this goal, 22 patients with out-of-hospital cardiac arrest (OHCA) treated by physicians of the prehospital physician response system located at the Medical University of Graz shall be included into this trial. All patients will receive Advanced Life Support (ALS) interventions according to current guidelines issued by the European Resuscitation Council (ERC). In addition, arterial lines will be placed and arterial blood pressure will be measured continuously. This intervention is already considered standard of care at this prehospital physician response system and performed routinely as part of the local ALS algorithm.
Relevant parameters - systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP) etc. - will be documented electronically using both the electronic documentation system already used by the prehospital physician response system and the monitor/defibrillator device. Median values will be compared between survivors and non-survivors and possible threshold values will be calculated. Cutoff values that would be best suited to act as targets in future research and clinical practice will be identified by receiver operating characteristics (ROC).
- Conditions
- Cardiac Arrest
- Medical subject headings
- Heart Arrest
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 |
|---|---|---|
| Survivors | Patients suffering from out-of-hospital cardiac arrest (OHCA), who achieve sustained return of spontaneous circulation (ROSC) following prehospital cardiopulmonary resuscitation. | |
| Non-Survivors | Patients suffering from out-of-hospital cardiac arrest (OHCA), who are declared dead after prehospital cardiopulmonary resuscitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Blood Pressure
Mean arterial blood pressure measured invasively via the arterial line.
Measured: immediately after placement of the arterial line
Secondary outcomes (8)
Systolic Arterial Blood Pressure
Systolic arterial blood pressure measured invasively via the arterial line.
Measured: immediately after placement of the arterial line
Diastolic Arterial Blood Pressure
Diastolic arterial blood pressure measured invasively via the arterial line.
Measured: immediately after placement of the arterial line
Mean Arterial Blood Pressure
Mean arterial blood pressure measured invasively via the arterial line.
Measured: one minute after the first application of epinephrine following placement of the arterial line
Systolic Arterial Blood Pressure
Systolic arterial blood pressure measured invasively via the arterial line.
Measured: one minute after the first application of epinephrine following placement of the arterial line
Diastolic Arterial Blood Pressure
Diastolic arterial blood pressure measured invasively via the arterial line.
Measured: one minute after the first application of epinephrine following placement of the arterial line
Mean Arterial Blood Pressure
Mean arterial blood pressure measured invasively via the arterial line.
Measured: five minutes after placement of arterial line
Systolic Arterial Blood Pressure
Systolic arterial blood pressure measured invasively via the arterial line.
Measured: five minutes after placement of arterial line
Diastolic Arterial Blood Pressure
Diastolic arterial blood pressure measured invasively via the arterial line.
Measured: five minutes after placement of arterial line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start7 Jun 2017
- Primary completion31 Dec 2020
- Study completion31 Mar 2021
Why it stopped: unable to facilitate patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Zajic, MD, Principal investigator, Div. of General Anaesthesiology, Emergency- and Intensive Care Medicine, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172468
- Sponsor's protocol ID
- HETOCA-2017-v1.1
- Acronym
- HETOCA
- Status last verified
- Jan 2025
- First submitted
- 15 May 2017
- Last updated
- 22 Jan 2025
- 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definition of Hemodynamic Thresholds in Out-of-Hospital Cardiac Arrest: Advancing Advanced Life Support Towards Goal Directed Resuscitation
- ClinicalTrials.gov ID
- NCT03172468
- Acronym / sponsor ID
- HETOCA / HETOCA-2017-v1.1
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: unable to facilitate patient recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 1 Jun 2017 (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.
This study seeks to evaluate, whether patients suffering from cardiac arrest, that can be successfully resuscitated, can be differentiated from those, that cannot be resuscitated, using arterial blood pressure values.
Detailed description
Cardiopulmonary resuscitation (CPR) in patients suffering from cardiac arrest out of hospitals is based on strict clinical practice guidelines. However, the evidence base for these treatment recommendation is insufficient in many respects. While knowledge about basic interventions, that are capable of restoring spontaneous circulation and improving neurologically intact survival - chest compressions, application of oxygen and early defibrillation -, has increased over the last decade, advanced treatment options - advanced airway management, vascular access, application of vasoactive drugs - are still recommended, although clinical trials of varying quality failed to demonstrate any benefit in patient related outcomes.
This study seeks to establish hemodynamic threshold values that are able to discriminate between patients that achieve return of spontaneous circulation (survivors) and those that fail to do so (non-survivors). These cutoff values could act as targets for interventions during CPR (i.e. application of vasoactive drugs, use of mechanical compression devices, …) in further trials and may potentially influence clinical practice later on. Furthermore, reliable cutoff values could act as additional prognostic factors during CPR, enabling prehospital care providers to base their decisions to continue or terminate ongoing CPR efforts on a more solid basis.
To achieve this goal, 22 patients with out-of-hospital cardiac arrest (OHCA) treated by physicians of the prehospital physician response system located at the Medical University of Graz shall be included into this trial. All patients will receive Advanced Life Support (ALS) interventions according to current guidelines issued by the European Resuscitation Council (ERC). In addition, arterial lines will be placed and arterial blood pressure will be measured continuously. This intervention is already considered standard of care at this prehospital physician response system and performed routinely as part of the local ALS algorithm.
Relevant parameters - systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP) etc. - will be documented electronically using both the electronic documentation system already used by the prehospital physician response system and the monitor/defibrillator device. Median values will be compared between survivors and non-survivors and possible threshold values will be calculated. Cutoff values that would be best suited to act as targets in future research and clinical practice will be identified by receiver operating characteristics (ROC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | –Patients suffering from out-of-hospital cardiac arrest (OHCA), who achieve sustained return of spontaneous circulation (ROSC) following prehospital cardiopulmonary resuscitation. |
| Non-Survivors | – | –Patients suffering from out-of-hospital cardiac arrest (OHCA), who are declared dead after prehospital cardiopulmonary resuscitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients suffering from cardiac arrest on arrival of the physician response unit are to be included, if ALS is deemed reasonable by the emergency physician. The groups to be compared are survivors (patients with sustained return of spontaneous circulation (ROSC) in the field who are transported to a hospital alive) and non-survivors (patients in whom CPR is terminated in the field).
Key inclusion criteria (4 listed)
- Out-of-hospital cardiac arrest
- Age >18 years
- Advanced Life Support started
- Arterial line placement possible
Key exclusion criteria (4 listed)
- Obvious signs of death
- Advanced Directives / Do Not Attempt Resuscitation Order
- Cardiac arrest of traumatic etiology
- Documented patient refusal in advance
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
Mean Arterial Blood Pressure
Time frame: immediately after placement of the arterial line
Mean arterial blood pressure measured invasively via the arterial line.
8 secondary outcomes
Systolic Arterial Blood Pressure
Time frame: immediately after placement of the arterial line
Diastolic Arterial Blood Pressure
Time frame: immediately after placement of the arterial line
Mean Arterial Blood Pressure
Time frame: one minute after the first application of epinephrine following placement of the arterial line
Systolic Arterial Blood Pressure
Time frame: one minute after the first application of epinephrine following placement of the arterial line
Diastolic Arterial Blood Pressure
Time frame: one minute after the first application of epinephrine following placement of the arterial line
Mean Arterial Blood Pressure
Time frame: five minutes after placement of arterial line
Systolic Arterial Blood Pressure
Time frame: five minutes after placement of arterial line
Diastolic Arterial Blood Pressure
Time frame: five minutes after placement of arterial line
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Paul Zajic, MD principal investigator
Div. of General Anaesthesiology, Emergency- and Intensive Care Medicine, Medical University of Graz
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 Cardiac Arrest, run by Medical University of Graz at 1 site in Austria.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 22 Jan 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 Austria. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Blood Pressure (time frame: immediately after placement of the arterial line). 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 22 Jan 2025.