Palliative SedationPALLSEDNCT04719702
The Clinical Practice of Palliative Sedation
An observational study of Palliative Sedation, run by Radboud University Medical Center at 8 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Sedation
- How many people
- 80 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 20 Apr 2021to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Netherlands4 sites
Rijnstate Ziekenhuis
Arnhem, 6815 AD
Radboud University Medical Centre
Nijmegen, 6500 HB
Hospice Bethlehem - Kalorama
Nijmegen, 6511 TR
Hospice de Hazelaar, Liemerije
Zevenaar, 6903 ZN
About this study
Official title: Palliative Sedation Across European Settings: a Prospective Observational Multicentre Study
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.
Read more
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:
- To evaluate the effect of palliative sedation on participants' comfort and other symptoms in different international hospices, palliative care units and hospital ward settings.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Change in levels of agitation and sedation of participants receiving a form of palliative sedation will be measured by the Richmond Agitation Sedation Scale-modified version for Palliative Care (RASS-PAL). This scale is a modified version of the RASS. The RASS-PAL is a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS-PAL level 0 is "alert and calm."
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start20 Apr 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative SedationStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, European Association for Palliative Care, KU Leuven, University Hospital, Bonn, Clinica Universidad de Navarra, Universidad de Navarra, La Maddalena SPA, Palermo
- Responsible party
- Sponsor
- Investigators
- Jeroen GJ Hasselaar, MSc, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719702
- Sponsor's protocol ID
- NL72725.091.20
- Other IDs
- 825700
- Acronym
- PALLSED
- Status last verified
- Jun 2024
- First submitted
- 11 Jan 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39741317Rijpstra 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.
PubMed 36709271
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Sedation Across European Settings: a Prospective Observational Multicentre Study
- ClinicalTrials.gov ID
- NCT04719702
- Acronym / sponsor ID
- PALLSED / NL72725.091.20
- Conditions
- Palliative Sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- European Union, European Association for Palliative Care, KU Leuven, University Hospital, Bonn, Clinica Universidad de Navarra, Universidad de Navarra, La Maddalena SPA, Palermo
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the effect of palliative sedation on participants' comfort and other symptoms in different international hospices, palliative care units and hospital ward settings.
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Levels of discomfort
Time frame: 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
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.
1 secondary outcome
Levels of agitation and sedation
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 39741317Rijpstra 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.
- Derived from this study: PubMed 36709271Rijpstra 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.
- Individual participant dataSharing planned: No
Related trials for Palliative Sedation
Not yet recruiting
End-of-life Care in Mechanically Ventilated Patients: Impact of a Comprehensive Palliative Care Protocol in the Intensive Care Setting
Palliative Care, Withdrawal of Life Support
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeroen GJ Hasselaar, MSc, PhD principal investigator
Radboud University Medical Center
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Sedation, run by Radboud University Medical Center at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands, Belgium, Germany, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of discomfort (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04719702, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.