NCT06984471

Brief Summary

The aim of this retrospective observational single-center cohort study is to investigate the factors associated with palliative care (PC) referral, examine intensive care unit (ICU) involvement before, during, or after the referral, and evaluate patient outcomes such as mortality, hospital and ICU length of stay, discharge destination, functional status, symptom management, and the content of PC consultation reports.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
532

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

May 8, 2025

Last Update Submit

May 21, 2025

Conditions

Keywords

Intensive Care Unit

Outcome Measures

Primary Outcomes (20)

  • Patient demographics

    Demographic information (e.g. age, sex) is collected.

    2019-2024

  • Acute prehospital management data

    Data from acute prehospital management, as documented in emergency medical services (EMS) treatment protocols, is collected. The collected data elements are aggregated to describe the overall EMS response.

    2019-2024

  • Duration of intensive care unit stay

    The length of intensive care unit (ICU) stay is recorded.

    2019-2024

  • Duration of hospital stay

    The length of the total hospital stay is recorded.

    2019-2024

  • Discharge destination

    The destination at discharge is recorded.

    2019-2024

  • Date of palliative care consult

    The specific date of palliative care consult is documented.

    2019-2024

  • Reason for palliative care consult

    The documented reason for palliative care consult is analyzed.

    2019-2024

  • Place of palliative care consult

    The specific place of palliative care consult is documented.

    2019-2024

  • Number of visits by the palliative care team

    The number of visits by the palliative care team is analyzed.

    2019-2024

  • Additional features of the palliative care consult

    Assessment of additional features related to the palliative care consult (changes in management, referral for psychiatric or psychological evaluation, treatment recommendations, etc.) documented in the medical records or consult report. These features are aggregated to characterize the scope, complexity, and potential impact of the palliative care consultation on the patient's overall treatment and care trajectory.

    2019-2024

  • Comprehensive assessment of the neurological status based on validated clinical assessment

    Neurological status during ICU stay is assessed using available data in the patient register from validated neurological assessments. These may include the Richmond Agitation-Sedation Scale (RASS), Sedation-Agitation Scale (SAS), Glasgow Coma Scale (GCS), Intensive Care Delirium Screening Checklist (ICDSC), or Status Epilepticus Severity Score (STESS). The specific tool used, as well as the scale of the score and meaning behind the score, depends on routine clinical practice and available documentation in the register. If multiple scores are available for a patient, they will be aggregated to provide a comprehensive assessment of neurological status. This outcome will be reported as a descriptive summary, synthesizing findings across tools, rather than as a single quantitative score.

    2019-2024

  • Comprehensive assessment of critical illness severity based on standardized scoring systems

    Disease severity during ICU stay is assessed using standardized scoring systems, including the Acute Physiology and Chronic Health Evaluation II (APACHE II), Simplified Acute Physiology Score II (SAPS II), and Sequential Organ Failure Assessment (SOFA), depending on data availability in the patient register. The specific scoring system applied, as well as the scale and interpretation of the score, varies based on routine clinical practice and available documentation. Where multiple severity scores are available, they will be synthesized to provide a descriptive summary of overall illness severity rather than a single quantitative score.

    2019-2024

  • Charlson Comorbidity Index

    The Charlson Comorbidity Index (CCI) is calculated based on pre-existing comorbidities and additional diagnoses. The CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. It assigns weighted scores (from 0 to maximal 6) to 17 comorbid conditions (e.g., heart disease, diabetes, cancer), resulting in a total score ranging from 0 to 33, if the patient had the most severe form of each of the 17 conditions.

    2019-2024

  • Laboratory parameters

    Routine laboratory value for e.g. C-Reactive Protein (CRP), albumin, Lactate Dehydrogenase (LDH), Creatine Kinase (CK), procalcitonin, white blood cell levels, creatinine, liver enzymes, blood gas analyses, metabolic data, etc. is collected. The specific parameters recorded may vary depending on the laboratory assessments documented in the patient register. All values will be reported using their respective units of measurement.These parameters are aggregated to support an overall clinical interpretation rather than a single numerical value. This approach reflects standard clinical practice, where multiple lab values are considered together to assess a patient's condition.

    2019-2024

  • Complications associated with palliative Care consult

    The complications occurring during or after the palliative care consultation are recorded, including inadequate symptom control, dissatisfaction expressed by the patient or relatives, cardiac arrest, unplanned emergency transfers to the ICU, and poor functional outcomes.

    2019-2024

  • Glasgow Outcome Score

    The Glasgow Outcome Score (GOS) is calculated based on the assessment of key clinical outcomes such as inhospital mortality, survival, survival with neurofunctional alteration, return to premorbid neurological function, and hospital readmission to determine the patient outcome. The GOS ranges from 1 (death) to 5 (good recovery).

    2019-2024

  • Therapeutic intervention

    The therapeutic intervention is documented, including information on duration, dosage and number of treatment medication, number of neuroleptic, sedative and analgesic drugs, invasive procedures, such as intubation, mechanical, ventilation, vasopressors, installation of central lines, nutrition, etc.

    2019-2024

  • Vital signs

    Vital signs are analyzed based on the data available in the patient register. These may include blood pressure, heart rate, respiratory rate, oxygen saturation, body temperature, level of consciousness, etc. The specific parameters recorded depend on the clinical documentation available. All values will be reported using their respective units of measurement. These values are aggregated to support an overall clinical assessment rather than a single numerical score. This reflects standard practice, where multiple vital signs are interpreted together to evaluate a patient's condition.

    2019-2024

  • Fluid balance data

    Fluid balance data, including the administration of fluids such as blood products, crystalloids, and enteral/parenteral nutrition, are documented. These components are aggregated to represent overall fluid input for each patient.

    2019-2024

  • Assessment of diagnostic procedure

    The diagnostic procedures performed during intensive care-whether invasive (e.g., lumbar puncture, central line placement) or non-invasive (e.g., radiologic imaging, ultrasound)-are systematically documented. Additionally, if physical restraints are used to ensure patient safety or procedural success, their usage are also recorded.

    2019-2024

Study Arms (3)

Before ICU stay

Adult patients with a PC consult before an ICU stay at the University Hospital Basel between 2019 and until the end of 2024.

Other: Palliative care consult

During ICU stay

Adult patients with a PC consult during an ICU stay at the University Hospital Basel between 2019 and until the end of 2024.

Other: Palliative care consult

After ICU stay

Adult patients with a PC consult after an ICU stay at the University Hospital Basel between 2019 and until the end of 2024.

Other: Palliative care consult

Interventions

A palliative care (PC) consult involves a specialized palliative care team to provide symptom management, psychosocial support, and assistance with goals-of-care discussions for patients with serious or life-limiting illnesses.

After ICU stayBefore ICU stayDuring ICU stay

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All consecutive adult patients (i.e. \>= 18 years of age) that received a palliative care consult in the same hospitalization as their ICU stay at the University Hospital Basel between 2019 and until the end of 2024. .

You may qualify if:

  • Adult patients (i.e., patients ≥18 years of age)
  • Palliative care consult either before, during or after a ICU stay at the University Hospital Basel between 2019 and until the end of 2024

You may not qualify if:

  • Patients younger than 18 years
  • Patients with documented refusal to use data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Clinic for Intensive Care Medicine

Basel, 4031, Switzerland

Location

Study Officials

  • Raoul Sutter, Prof. Dr. med.

    University Hospital Basel, Clinic for Intensive Care Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 22, 2025

Study Start

May 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 22, 2025

Record last verified: 2025-05

Locations