ICU Background Early Awareness for Critical deterioratiON
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorETH Zurich
About this trial
The study will compare ICU sub-units, those with additional support of a clinician awareness system, ICU Beacon, and those receiving the standard of care. The win-ratio composite outcome will be assessed by comparing patients by study group and stratified by APACHE score at admission.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
admission to intensive care unit
Disqualifiers
age < 18 years
presence of documented refused general consent form (at database closure)
admission for the sole purpose of dying/organ donation or evaluation of such
Trial population
The study population includes all patients admitted to the Inselspital Bern ICU, not fulfilling any of the exclusion criteria.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
ICU Beacon
Other interventionAvailability of a proprietary clinician awareness for potential organ deterioration software to treating clinicians (ICU Beacon) in addition to the standard of care.
Treatment groups
1,962 Participants
are divided into 2 treatment groupsGroup A: Control Group0 interventions
Group B: Study Group1 intervention
Trial outcomes
Primary outcomes
1
The primary objective is to determine whether BEACON improves ICU sub-unit performance, i.e. reduces total mortality and/or mitigates severity of organ failures in an adult university ICU setting.
Determined by a stratified clustered hierarchical win ratio. Patient data is clustered by ICU sub-unit and stratified by APACHE score. For each stratum, each patient in the study group is compared with all patients in the control group within that same stratum. Levels are assessed up to 28 days after admission. The hierarchical levels are: 1. All-cause mortality; 2. Number of organ systems failed (respiratory, cardiovascular, coagulation, liver, renal) with SOFA scores newly increasing to 3 points during the ICU stay; and 3. Sum of highest circulatory and respiratory SOFA scores during the ICU stay, independently assessed and subsequently summed. If one patient "wins" at the first level (i.e., is alive while the other is dead), the comparison is decided. If a tie occurs (both alive or both dead at at 28 days), the next level is compared, and so forth. This approach prioritizes the most clinically serious outcome (mortality), while capturing organ dysfunction at different levels.
Time frame
Patient data up to 28 days post admission will be collected to support analysis.Secondary outcomes
1
Time free of circulatory failure and alive at 28 days
Described by the total number of days the patient was alive and free of circulatory failure within the first 28 days after admission. Circulatory failure is defined as: lactate \>= 2 mmol/L and MAP \<= 65 mmHg or receipt of vasopressors/inotropes.
Time frame
Patient data up to 28 days post admission will be collected to support analysis.2
Time free of respiratory failure and alive at 28 days
Described by the total number of days the patient was alive and free of respiratory failure within the first 28 days after admission. Respiratory failure is defined as: (PaO2/FiO2 ratio \< 150 mmHg).
Time frame
Patient data up to 28 days post admission will be collected to support analysis.3
All cause mortality at 28 days
Mortality from any cause within 28 days following ICU admission.
Time frame
Patient data up to 28 days post admission will be collected to support analysis.4
Mean total SOFA score over ICU stay
The mean SOFA score including all organ systems through the duration of the ICU admission.
Time frame
Patient data up to 28 days post admission will be collected to support analysis.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
ETH Zurich
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborator
Source ClinicalTrials.gov