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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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

Other trials in Austria

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 groups in NCT03172468
Study groupRoleWhat they receive
SurvivorsPatients suffering from out-of-hospital cardiac arrest (OHCA), who achieve sustained return of spontaneous circulation (ROSC) following prehospital cardiopulmonary resuscitation.
Non-SurvivorsPatients 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.

  1. 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)
  1. Systolic Arterial Blood Pressure

    Systolic arterial blood pressure measured invasively via the arterial line.

    Measured: immediately after placement of the arterial line

  2. Diastolic Arterial Blood Pressure

    Diastolic arterial blood pressure measured invasively via the arterial line.

    Measured: immediately after placement of the arterial line

  3. 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

  4. 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

  5. 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

  6. Mean Arterial Blood Pressure

    Mean arterial blood pressure measured invasively via the arterial line.

    Measured: five minutes after placement of arterial line

  7. Systolic Arterial Blood Pressure

    Systolic arterial blood pressure measured invasively via the arterial line.

    Measured: five minutes after placement of arterial line

  8. 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.

  1. First posted1 Jun 2017
  2. Study start7 Jun 2017
  3. Primary completion31 Dec 2020
  4. Study completion31 Mar 2021

Why it stopped: unable to facilitate patient recruitment

Resources

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)
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

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.

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