Definition of Hemodynamic Thresholds in Out-of-Hospital Cardiac Arrest

NCT ID: NCT03172468

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-07
• Study Completion Date: 2021-03-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Survivors

Patients suffering from out-of-hospital cardiac arrest (OHCA), who achieve sustained return of spontaneous circulation (ROSC) following prehospital cardiopulmonary resuscitation.

No interventions assigned to this group

Non-Survivors

Patients suffering from out-of-hospital cardiac arrest (OHCA), who are declared dead after prehospital cardiopulmonary resuscitation.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Zajic, MD

Role: PRINCIPAL_INVESTIGATOR

Div. of General Anaesthesiology, Emergency- and Intensive Care Medicine, Medical University of Graz

Locations

Prehospital Physician Response System, Medical University of Graz

Graz, Styria, Austria

Countries

Austria

Study Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Other Identifiers

HETOCA-2017-v1.1

Identifier Type: -

Identifier Source: org_study_id