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The Clinical Practice of Palliative Sedation

NCT04719702 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-07-03

No results posted yet for this study

Summary

Palliative Sedation (PS) is defined as the intentional lowering of consciousness of a patient in the last phase of life, to relieve patients suffering from refractory symptoms. For those symptoms all possible effective treatments, within an acceptable timeframe, are exhausted.

Several studies have been performed about palliative sedation, mostly focusing on continuous deep sedation, with the use of various measurements to monitor its effect. Efficacy of continuous palliative sedation has been monitored by agitation/distress levels, symptom control, levels of sedation/awareness, comfort, safety and family/caregivers satisfaction. Differences between studies occur, for instance in definition, application and monitoring. Consequently reported outcomes and associated treatment goals differ between studies which makes it difficult to compare the results.

Within this international multicenter observational study, the investigators aim to evaluate the effects of palliative sedation on patient's comfort levels. Participants with different forms and intensity of palliative sedation (intermittent and continuous, from light to deep) are included in a prospective design as part of an international study.

Objectives:

1. To evaluate the effect of palliative sedation on participants' comfort and other symptoms in different international hospices, palliative care units and hospital ward settings.
2. To assess the clinical practice of palliative sedation in different international care settings and the accompanying costs and consequences.

Study design: Prospective observational multicentre study in hospices, palliative care units and hospital ward settings in five European countries (Belgium, Germany, Italy, Spain, The Netherlands).

Conditions

  • Palliative Sedation

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • European Association for Palliative Care (EAPC)

    collaborator UNKNOWN

  • KU Leuven

    collaborator OTHER

  • University Hospital, Bonn

    collaborator OTHER

  • Clinica Universidad de Navarra, Universidad de Navarra

    collaborator OTHER

  • La Maddalena SPA, Palermo

    collaborator UNKNOWN

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Jeroen GJ Hasselaar, MSc, PhD · Radboud University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Belgium
  • Germany
  • Italy
  • Netherlands
  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04719702 on ClinicalTrials.gov