PREDOHCA: Prediction of Outcome in Out-of-Hospital Cardiac Arrest

Sponsor
Kepler University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06030986
Collaborator
(none)
10,000
1
2
4989.8

Study Details

Study Description

Brief Summary

In the course of prehospital respiratory and circulatory arrest, approximately 1000 persons are resuscitated by cardiopulmonary resuscitation in Upper Austria every year. Despite constant further development of methods, equipment and continuous training of the rescue and emergency medical teams working on site, the majority of patients who have to be resuscitated prehospital still die. However, even patients whose circulatory function can be restored during prehospital resuscitation (Return of Spontaneous Circulation, ROSC) require intensive medical care for days to weeks and often find it very difficult to return to a normal, independent life.

The success of resuscitation measures depends on the quality of the resuscitation performed as well as on patient-specific factors. Evaluation scales such as the Cerebral Performance Category score (CPC) allow a posteriori assessment of resuscitation success. Nowadays, it is very difficult to estimate the outcome of resuscitation a priori. In many cases, it is not at all clear at the beginning of the treatment pathway whether the individual patient is expected to have an unfavorable prognosis in the context of respiratory arrest or whether a restitutio ad integrum is possible.

Thus, the decision to continue or discontinue resuscitation can only be made on the basis of an individual physician's assessment. In addition to the primary concern of stopping resuscitation too early, there is also the risk that medical resources are used beyond the normal level after resuscitation without expecting a successful outcome. Estimating and categorizing the subsequent outcome is difficult and emotionally stressful for the treating team in the acute situation. Some factors that influence outcome are now known: As cerebral hypoperfusion increases, the probability of survival decreases sharply with each passing minute. In this context, potentially reversible causes have been identified in different works, allowing causal therapy to improve neurological outcome. In addition to the most important therapy bridging hypoperfusion, chest compression, with the aim of ensuring minimal perfusion of the brain, immediate defibrillation should be mentioned in particular, which now allows medical laypersons to use defibrillators as part of the Public Access Defibrillation Network.

Despite all efforts, however, it is not yet possible to make reliable statements about the probable outcome of persons with respiratory and circulatory arrest with a high degree of certainty in a large number of cases at an early stage.

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Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ILCOR Utstein OHCA Core Outcome

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Prediction of Outcome in Out-of-Hospital Cardiac Arrest
Anticipated Study Start Date :
Oct 31, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
ILCOR Utstein OHCA Core Outcome Positive

Respectively for all core outcomes defined.

Diagnostic Test: ILCOR Utstein OHCA Core Outcome
ILCOR Utstein OHCA Core Outcome

ILCOR Utstein OHCA Core Outcome Negative

Respectively for all core outcomes defined.

Diagnostic Test: ILCOR Utstein OHCA Core Outcome
ILCOR Utstein OHCA Core Outcome

Outcome Measures

Primary Outcome Measures

  1. AUC-ROC for Prediction of ILCOR Utstein OHCA Core Outcome [2015-01-01 - 2023-10-31]

    AUC-ROC for Prediction of ILCOR Utstein OHCA Core Outcome

  2. AUC-PRC for Prediction of ILCOR Utstein OHCA Core Outcome [2015-01-01 - 2023-10-31]

    AUC-PRC for Prediction of ILCOR Utstein OHCA Core Outcome

  3. F1-Score for Prediction of ILCOR Utstein OHCA Core Outcome [2015-01-01 - 2023-10-31]

    F1-Score for Prediction of ILCOR Utstein OHCA Core Outcome

  4. Confusion Matrix for Prediction of ILCOR Utstein OHCA Core Outcome [2015-01-01 to 2023-10-31]

    Confusion Matrix for Prediction of ILCOR Utstein OHCA Core Outcome

Secondary Outcome Measures

  1. AUC-ROC for Prediction of Diagnosis at Hospital Discharge [2015-01-01 - 2023-10-31]

    AUC-ROC for Prediction of Diagnosis at Hospital Discharge

  2. AUC-PRC for Prediction of Diagnosis at Hospital Discharge [2015-01-01 - 2023-10-31]

    AUC-PRC for Prediction of Diagnosis at Hospital Discharge

  3. F1-Score for Prediction of Diagnosis at Hospital Discharge [2015-01-01 - 2023-10-31]

    F1-Score for Prediction of Diagnosis at Hospital Discharge

  4. Confusion Matrix for Prediction of Diagnosis at Hospital Discharge [2015-01-01 - 2023-10-31]

    Confusion Matrix for Prediction of Diagnosis at Hospital Discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients 18 years or older AND

  • between 2015-01-01 and 2023-10-31 AND

  • have been treated by emergency medical teams of the Austrian Red Cross, District Branch of Upper Austria AND

  • have suffered out-of-hospital cardiac arrest AND

  • have been treated by emergency physicians while out of hospital AND

  • have been transported to the Kepler University Hospital, Linz, Austria

Exclusion Criteria:
  • none

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kepler University Hospital Linz Upper Austria Austria 4020

Sponsors and Collaborators

  • Kepler University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kepler University Hospital
ClinicalTrials.gov Identifier:
NCT06030986
Other Study ID Numbers:
  • PREDOHCA
First Posted:
Sep 11, 2023
Last Update Posted:
Sep 11, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 11, 2023