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NCT Number: NCT07119411

ICU Background Early Awareness for Critical deterioratiON

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.

Recruiting

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Key information

Conditions

Respiratory Failure Circulatory Failure Mortality Multiple Organ Failure Organ Dysfunction Organ Failure, Multiple Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital - Universitätsspital Bern

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Martin Faltys, Dr. med.

CONTACT

[email protected]

+41 31 632 2111

Martin Faltys, Dr. med.

PRINCIPAL_INVESTIGATOR

About this study

Single-center, stratified, cluster-randomized (the ICU units will be randomized) crossover analysis with outcome-assessor blinding. The analysis will be conducted in the adult intensive care units (ICUs) of Inselspital, Bern, comprising two distinct ICU units: the Blue and the Yellow ICU Unit. Each unit contains two sub-units, which will serve as the clustering units for randomization. The study follows a two-phase design. In the initial phase, sub-units within each ICU unit will be randomly allocated in a 1:1 ratio to either the additional BEACON scoring group or control group. Patients admitted to sub-units allocated to the BEACON group will receive standard care plus BEACON scores, while those admitted to control group will receive standard care only. After predefined cluster periods, allocations will be swapped between the BEACON and control groups. A wash-out period of two weeks will be observed between swaps to minimize carryover effects. During the wash-out period, no new study patients will be enrolled. Once the swap is complete, only newly admitted patients will be enrolled under the sub-unit's new allocation. Patients still occupying sub-units from the preceding period will be censored from the study at the time of the swap and excluded from outcome analysis beyond that point. The same approach will be applied for patients who will be transferred from one unit to a different unit during the ICU admission for logistical/organizational reasons. Importantly, individual patients will only be exposed to one analysis condition-either the BEACON or control-based on the bed allocation at the time of their admission. Only the sub-units themselves undergo crossover, ensuring temporal balance while maintaining patient-level exposure to a single condition.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • admission to intensive care unit

Exclusion criteria

  • 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

Treatment and study plan

ICU Beacon

Other

Availability of a proprietary clinician awareness for potential organ deterioration software to treating clinicians (ICU Beacon) in addition to the standard of care.

Other names: Beacon

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.

    Time frame: Patient data up to 28 days post admission will be collected to support analysis.

    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:

    • All-cause mortality;
    • Number of organ systems failed (respiratory, cardiovascular, coagulation, liver, renal) with SOFA scores newly increasing to 3 points during the ICU stay; and
    • 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.

Secondary outcomes

  1. Time free of circulatory failure and alive at 28 days

    Time frame: Patient data up to 28 days post admission will be collected to support analysis.

    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.

  2. Time free of respiratory failure and alive at 28 days

    Time frame: Patient data up to 28 days post admission will be collected to support analysis.

    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).

  3. All cause mortality at 28 days

    Time frame: Patient data up to 28 days post admission will be collected to support analysis.

    Mortality from any cause within 28 days following ICU admission.

  4. Mean total SOFA score over ICU stay

    Time frame: Patient data up to 28 days post admission will be collected to support analysis.

    The mean SOFA score including all organ systems through the duration of the ICU admission.

Study contacts

Contact information is provided by the study sponsor or research team.

Gunnar Rätsch, Dr. rer. nat.

CONTACT

[email protected]

+41 44 632 2036

Quinten Johnson

CONTACT

[email protected]

+41 78 300 9997

Sponsors and collaborators

Lead sponsor

ETH Zurich

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern

Registry information

Official study title

ICU Background Early Awareness for Critical deterioratiON (BEACON)

Acronym: BEACON

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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