Clinical trial NCT05471193: Prediction of Cardiac Instability in Intensive Care
Official title: Prediction of Cardiac Instability in Intensive Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamics
Lead sponsor: Kepler University Hospital
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 3069
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As described in the inclusion criteria.

Brief summary: A large number of different organ functions are recorded in real time for patients who are monitored in an intensive care unit. On the one hand, the measured values collected in this way are used for continuous monitoring of vital parameters, but they are also evaluated several times a day in order to be able to make decisions regarding further diagnostics and therapy. In the first case, threshold values can be defined, and if these are exceeded or fallen short of, the treatment team is automatically alerted. If these limits are set too liberally, then the alert will only indicate an acute risk to the patient, where extensive pathophysiological changes have already occurred. If the limits are chosen too restrictively, then there are frequent false alarms, since the limits are exceeded in most cases due to natural fluctuation, without this having any pathological value. The consequence is a so-called "alarm fatigue", which in the worst case leads to ignoring correct alarms and thus endangers the patients. By design, all of these readings only show the status quo of a patient. It is the task of the treatment team to predict from the course of these readings whether a threatening situation is developing for the patient.

For daily clinical practice, it would be better if dangerous changes in vital signs could be predicted. In this case, it would be possible to intervene therapeutically not only when a dangerous situation has arisen, but to try to avert this situation through adequate measures by changing the therapy strategy. In such a case, the treatment team would no longer be confronted with emergency alarms, but could counteract an impending deterioration with a long lead time.

The first approaches for detecting a drop in blood pressure, for example, which are based on simple models, are already in clinical use.


Eligibility criteria: Inclusion Criteria:

* All adult patients that have been treated at the intensive care units of the Kepler University Hospital, Linz, Austria between 2018-03-01 and 2020-10-31.

Exclusion Criteria:

* None.

Primary outcomes:
measure: AUROC for Classification of Instability
timeFrame: 2018-03-01 to 2020-10-31
Secondary outcomes:
measure: Confusion Matrix
timeFrame: 2018-03-01 to 2020-10-31
measure: Descriptive Statistics This outcome measure will compare the individual feature (e. g. height in cm) in one group vs. the other. Significant difference will be described by p-value.
timeFrame: 2018-03-01 to 2020-10-31
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler University Hospital
state: Upper Austria
Study officials:
affiliation: Kepler University Hospital and Johannes Kepler University, Linz, Austria
name: Thomas Tschoellitsch, MD
role: PRINCIPAL_INVESTIGATOR
References: