Clinical trial NCT04719702: The Clinical Practice of Palliative Sedation
Official title: Palliative Sedation Across European Settings: a Prospective Observational Multicentre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Palliative Sedation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: European Union
name: European Association for Palliative Care (EAPC)
name: KU Leuven
name: University Hospital, Bonn
name: Clinica Universidad de Navarra, Universidad de Navarra
name: La Maddalena SPA, Palermo
First posted: 2021-01-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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. 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).


Eligibility criteria: Phase 1: Participants are eligible for participation in this study when they meet all the following criteria:

* Adults;
* with advanced cancer;
* and a limited life expectancy (1- 2 months);
* according the health care team, intractable distress caused by one or more refractory symptoms can be expected or is present during the hospitalization.

Participants can enter Phase 2 of this study when fulfilling the following preconditions:

* inclusion criteria for phase 1 are met and informed consent is given by the participant;
* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Levels of discomfort
timeFrame: 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:
measure: Levels of agitation and sedation
timeFrame: 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:
measure: Changes in dosage of administered sedative medication during Palliative Sedation
timeFrame: Daily Registration from start PS until the date of death, on average less than 1 week
measure: Changes in sort of administered sedative medication during Palliative Sedation
timeFrame: Daily Registration from start PS until the date of death, on average less than 1 week
measure: Changes in route of administered medication during Palliative Sedation
timeFrame: Daily Registration from start PS until the date of death, on average less than 1 week
measure: Amount of staff time (in minutes) needed for tasks in different phases of PS
timeFrame: T1: During the decision process; T2: Start/Initiation of PS; T3-T..: Daily registration of time until the death date, on average 1 week
measure: Satisfaction with care during the palliative sedation period by one of the relatives
timeFrame: T1: Once, One month after the participant's death the relative receives the questionnaire.
measure: Evaluation of the palliative sedation period of the patient by one of the Health Care Professionals (HCP)
timeFrame: T1: Once, within one week after the participant's death the HCP receives the questionnaire.
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Palermo
country: Italy
facility: La Maddalena Spa
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre
city: Nijmegen
country: Netherlands
facility: Hospice Bethlehem - Kalorama
city: Zevenaar
country: Netherlands
facility: Hospice de Hazelaar, Liemerije
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
Study officials:
affiliation: Radboud University Medical Center
name: Jeroen GJ Hasselaar, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: