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Definition of Hemodynamic Thresholds in Out-of-Hospital Cardiac Arrest (HETOCA)

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ClinicalTrials.gov Identifier: NCT03172468
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief 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.

Condition or disease
Cardiac Arrest

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 Type : Observational
Estimated Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Definition of Hemodynamic Thresholds in Out-of-Hospital Cardiac Arrest: Advancing Advanced Life Support Towards Goal Directed Resuscitation
Actual Study Start Date : June 7, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Mean Arterial Blood Pressure [ Time Frame: immediately after placement of the arterial line ]
    Mean arterial blood pressure measured invasively via the arterial line.


Secondary Outcome Measures :
  1. Systolic Arterial Blood Pressure [ Time Frame: immediately after placement of the arterial line ]
    Systolic arterial blood pressure measured invasively via the arterial line.

  2. Diastolic Arterial Blood Pressure [ Time Frame: immediately after placement of the arterial line ]
    Diastolic arterial blood pressure measured invasively via the arterial line.

  3. Mean Arterial Blood Pressure [ Time Frame: one minute after the first application of epinephrine following placement of the arterial line ]
    Mean arterial blood pressure measured invasively via the arterial line.

  4. Systolic Arterial Blood Pressure [ Time Frame: one minute after the first application of epinephrine following placement of the arterial line ]
    Systolic arterial blood pressure measured invasively via the arterial line.

  5. Diastolic Arterial Blood Pressure [ Time Frame: one minute after the first application of epinephrine following placement of the arterial line ]
    Diastolic arterial blood pressure measured invasively via the arterial line.

  6. Mean Arterial Blood Pressure [ Time Frame: five minutes after placement of arterial line ]
    Mean arterial blood pressure measured invasively via the arterial line.

  7. Systolic Arterial Blood Pressure [ Time Frame: five minutes after placement of arterial line ]
    Systolic arterial blood pressure measured invasively via the arterial line.

  8. Diastolic Arterial Blood Pressure [ Time Frame: five minutes after placement of arterial line ]
    Diastolic arterial blood pressure measured invasively via the arterial line.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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).
Criteria

Inclusion Criteria

  • Out-of-hospital cardiac arrest
  • Age >18 years
  • Advanced Life Support started
  • Arterial line placement possible

Exclusion Criteria

  • Obvious signs of death
  • Advanced Directives / Do Not Attempt Resuscitation Order
  • Cardiac arrest of traumatic etiology
  • Documented patient refusal in advance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172468


Contacts
Contact: Paul Zajic, MD +43 (0) 316 385 ext 80609 paul.zajic@medunigraz.at
Contact: Gerhard Prause, MD +43 (0) 316 385 ext 81170 gerhard.prause@medunigraz.at

Locations
Austria
Prehospital Physician Response System, Medical University of Graz Recruiting
Graz, Styria, Austria, 8036
Contact: Gerhard Prause, MD    +43 (0) 316 385 ext 81170    gerhard.prause@medunigraz.at   
Contact: Paul Zajic, MD    +43 (0) 316 385 ext 80609    paul.zajic@medunigraz.at   
Principal Investigator: Paul Zajic, MD         
Sub-Investigator: Gerhard Prause, MD         
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Paul Zajic, MD Div. of General Anaesthesiology, Emergency- and Intensive Care Medicine, Medical University of Graz

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03172468     History of Changes
Other Study ID Numbers: HETOCA-2017-v1.1
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases