The Clinical Practice of Palliative Sedation

NCT04719702 | Completed

• 2 other identifiers: NL72725.091.20825700
• Study Type: observational
• Target: 80
• Locations: 5 countries
• Sites: 8

Brief 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. 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. 2.To assess the clinical practice of palliative sedation in different international care settings and the accompanying costs and consequences.

Conditions

Palliative Sedation

Outcome Measures

Primary Outcomes (1)

• Levels of discomfort

  Change in discomfort levels of participants receiving a form of palliative sedation (PS) will be measured by the Discomfort Scale-Dementia of Alzheimer Type (DS-DAT). The tool covers nine categories: noisy breathing, negative vocalizations, content facial expression, sad facial expression, frightened facial expression, frown, relaxed body language, tense body language, and fidgeting. Items are scored by indicating behaviors that are present/absent with a resulting range of scores from 0 to 27. Higher scores represent higher amount of discomfort.

  T0: Baseline before start PS (max. 8 hours before); T1: First measurement after start PS, within 6 hours after start PS; T2-T..: Measurements are continued twice a day during PS until the date of death, on average less than 1 week

Secondary Outcomes (1)

• Levels of agitation and sedation

  T0: Baseline before start PS (max. 8 hours before); T1: First measurement after start PS, within 6 hours after start PS; T2-T..: Measurements are continued twice a day during PS until the date of death, on average less than 1 week

Other Outcomes (6)

• Changes in dosage of administered sedative medication during Palliative Sedation

  Daily Registration from start PS until the date of death, on average less than 1 week

• Changes in sort of administered sedative medication during Palliative Sedation

  Daily Registration from start PS until the date of death, on average less than 1 week

• Changes in route of administered medication during Palliative Sedation

  Daily Registration from start PS until the date of death, on average less than 1 week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutively admitted patients to one of the participating palliative care settings (PC units / consulted by PC team at the hospital wards / Hospices) will be screened for eligibility. Preferably, eligible particpants and/or their relatives are informed about the study in an early stage of their palliative care trajectory. Therefore, we use two phases: phase 1: admitted patients with advanced cancer and limited life expectancy; phase 2: deteriorating patient's and the decisionprocess about palliative sedation is started.

You may qualify if:

• participant is suffering from intractable distress caused by one or more refractory symptoms according the health care team and/or participant and relatives;
• sedative medication is started with the aim to relieve burden of otherwise intractable suffering (palliative sedation)

You may not qualify if:

• a potential participant is unable to give informed consent;
• a potential participant is unable to speak and read in the native language of the participating country.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• European Union: collaborator
• European Association for Palliative Care (EAPC): collaborator
• KU Leuven: collaborator
• University Hospital, Bonn: collaborator
• Clinica Universidad de Navarra, Universidad de Navarra: collaborator
• La Maddalena SPA, Palermo: collaborator

Study Sites (8)

Katholieke Universiteit Leuven

Leuven, Belgium

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

La Maddalena Spa

Palermo, 90146, Italy

Location

Rijnstate Ziekenhuis

Arnhem, 6815 AD, Netherlands

Location

Radboud University Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Hospice Bethlehem - Kalorama

Nijmegen, 6511 TR, Netherlands

Location

Hospice de Hazelaar, Liemerije

Zevenaar, 6903 ZN, Netherlands

Location

Clinica Universidad de Navarra

Pamplona, 31080, Spain

Location

Related Publications (2)

• Rijpstra M, Vissers K, Belar A, Van der Elst M, Surges SM, Adile C, Roji R, Grassi Y, Bronkhorst E, Mercadante S, Radbruch L, Menten J, Centeno C, Kuip E, Hasselaar J. Assessment of the efficacy of palliative sedation in advanced cancer patients by evaluating discomfort levels: a prospective, international, multicenter observational study. BMC Med. 2024 Dec 31;22(1):608. doi: 10.1186/s12916-024-03829-7.

  PMID: 39741317 DERIVED

• Rijpstra M, Vissers K, Centeno C, Menten J, Radbruch L, Mercadante S, Van der Elst M, Adile C, Arantzamendi M, Kuip E, Payne S, Preston N, Hasselaar J. Monitoring the clinical practice of palliative sedation (PALSED) in patients with advanced cancer: an international, multicentre, non-experimental prospective observational study protocol. BMC Palliat Care. 2023 Jan 28;22(1):8. doi: 10.1186/s12904-022-01125-w.

  PMID: 36709271 DERIVED

Study Officials

• Jeroen GJ Hasselaar, MSc, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 22, 2021
• Study Start: April 20, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4); ES (1); DE (1); BE (1); IT (1)