The Clinical Practice of Palliative Sedation (PALLSED)

Radboud University Medical Center

Status: Completed

Conditions: Palliative Sedation

Study type: Observational

Funder types: Other

Identifiers

NCT04719702

NL72725.091.20

825700 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.