Death rattle in the dying phase MedDRA version: 19.0 Level: LLT Classification code 10031920 Term: Other diseases of trachea and bronchus, not elsewhere classified System Organ Class: 100000004855
Conditions
Interventions
Product Name: scopolaminebutyl
Pharmaceutical Form: Solution for injection
INN or Proposed INN: butylscopolaminebromide
CAS Number: 149-64-4
Other descriptive name: HYOSCINE BUTYLBROMIDE
Concentration
Sponsors
Erasmus MC Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Admission for care and treatment in one of the participating hospice facilities 2. It is known by the patient and his/her relatives that the admission will be up to death 3. At admission life expectancy is at least 3 days 4. At explanation of the study (shortly after admission to hospice facility) and signing of the informed consent the patient is conscious 5. Presence of a signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1. There are signs of a respiratory infection (upper or lower respiratory tract) 2. The patient has a tracheostomy or tracheocanula 3. The patient uses an anticholinergic or octreotide 4. At the start/At recognition of the dying phase death rattle is present at grade 1 or more, according to Back
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Can administration of scopolaminebutyl from the start of the dying phase prevent death rattle during the dying phase?;Secondary Objective: Is the appearance of death rattle delayed by preventive administration of hyoscine butylbromide (HB) Does preventive administration of HB from the recognition of the dying phase induce side-effects as micturition, dry mouth and restlessness Is there: -a difference in the quality of death among patients treated with HB and placebo, according to survivors and caregivers -a difference in quality of life the last three days of the patient, according to the relatives and caregivers -a difference in quality of care during a stay and in the past three days between patients treated with HB and placebo, according to survivors -a difference in the way of death according to the relatives and caregivers -a difference in the moment of death, according to the survivors and the caregivers -a difference between the mourning relatives of patients treated with placebo and HB Which influence has participation in the study on the quality of death of the patient, according to survivors;Primary end point(s): The percentage of patients who develop death rattle, defined as the appearance of grade 2 or higher according to the method of Back measured at 2 successive times/time points with an interval of 4 hours. The following degrees of rattle are distinguished: grade 0 = no audible rattle grade 1 = rattle only audible close to the patient grade 2 = rattle in a quiet room clearly audible at the foot of the bed grade 3 = rattle in a quiet room audible at a distance of 10 meters (at the door of a room);Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time from recognition of the dying phase until death rattle - Appearance of the adverse events micturition, dry mouth and restlessness by observations noted in the digital Care plan of the dying (formerly known as Liverpool Care Pathway) - Quality of life during the last three days of the life of the patient, according to the caregiver, indicated by a numerical value on a scale of 0 to 10 (0 = no quality; 10 = the best quality that can be imagined) - Quality of dying of the patient, according to the caregiver, indicated by a numerical value on a scale of 0 to 10 (0 =no quality; 10 = the best quality that can be imagined ) - Manner of death, according to the caregiver, indicated with 15 qualitative terms. - Moment of death, according to the caregiver, indicated with 15 qualitative terms. - Quality of Life in the last three days of the patient according to the relatives, indicated with a numerical value on a scale of 0 to 10 (0 =no quality; 10 = the best quality that can be imagined ) - Quality of dying of the patient, indicated by the relatives, indicated with a numerical value on a scale of 0 to 10 (0 = no quality; 10 = the best quality that can be imagined ) - The way of dying, according to the relatives, indicated with 15 qualitative terms. - Moment of death, according to the relatives, indicated with 15 qualitative terms. - Extent of bereavement for relatives according to the Leiden Score (15) - Experience of participating in a (double-blind, placebo-controlled) scientific research trial through a questionnaire with questions about the perception and the meaning of participating in a trial indicated by a numerical value on a scale of 1 to 4 (1 = no stress; 4 = extremely stressful) ;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Netherlands
Contacts
Public ContactC. van Zuylen
Erasmus MC Cancer Institute
Outcome results
None listed