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Death rattle in the dying phase: is prophylactic treatment effective?


- candidate number27131
- NTR NumberNTR6438
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-apr-2017
- Secondary IDsNL 58109.078.16 / MEC 2016-429 / 2016-002287-14 ZonMW / EMC Rotterdam / EudraCT nummer
- Public TitleDeath rattle in the dying phase: is prophylactic treatment effective?
- Scientific TitleDeath rattle in the dying phase: is prophylactic treatment effective?
- ACRONYM
- hypothesisAbout half of the patients in the dying phase experience death rattle: noisy breathing caused by the presence of mucus in the upper respiratory tract. Patients may be afraid of the occurrence of death rattle. Memories of loved ones with this phenomena are often associated with choking. For the relatives its rattling noise can be unpleasant and disturbing. They may fear that their loved one suffers from it. Awareness and posture changes in bed are the recommended actions. If the rattle is nevertheless perceived as burdensome, drugs (anticholinergics) can be considered. However, there is no evidence for the effect of these drugs. Whereas anticholinergics do not affect existing mucus, it may be more effective when given preventively. We designed a study to test this hypothesis in patients admitted to a hospice.
- Healt Condition(s) or Problem(s) studiedDeath rattle
- Inclusion criteria1. Admission in one of the participating hospice facilities, 2. Patient and his/her relatives are aware that the inclusion will be up to death, 3. Life expectancy at admission of at least 3 days, 4. no signs of disturbed consciousness at the moment of asking informed consent (shortly after admission to hospice facility) and signing of the informed consent.
- Exclusion criteria1. Signs of active respiratory infection (upper or lower respiratory tract), 2. Tracheostomy or tracheal cannula in situ, 3. Use of an anticholinergic drug or octreotide, 4. At entering the dying phase death rattle grade 1 according to the scale of Back
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2017
- planned closingdate1-sep-2018
- Target number of participants200
- InterventionsAt the recognition of the dying phase the patient will start with scopolaminebutyl 20 mg(=1 ml) or placebo (=1 ml NaCl 0.9%) four times a day subcutaneously. Treatment will be continued until death or until the occurrence of death rattle with a severity of grade 2 according to the scale of Back at 2 consecutive measurements with an interval of 4 hours. Standard care as provided in the hospices will be continued.
- Primary outcomeThe percentage of patients who develop death rattle, as defined as the occurrence of death rattle with a severity of grade 2 according to the scale of Back at 2 consecutive measurements with an interval of 4 hours.
- Secondary outcome- Time from the recognition of the dying phase until the occurrence of death rattle (time in hours)
- Occurrence of adverse events, i.e. urinary retention, dry mouth and restlessness (yes/no )
- Quality of life during the last three days and quality of dying, both according to the caregiver and relatives ( 0-10 numeric rating scale)
- Quality of dying process , according to the caregiver and relatives (15 qualitative descriptions)
- Bereavement of relatives according to the Leiden Detachment Scale
- Experience of relatives on the patient's participating in a (double-blind, placebo-controlled) clinical trial (questionnaire)
- TimepointsFrom the start of the dying phase every four hours observations are made by the nursing staff. They report these observations in the Care Pathway for the Dying, which will be started at the moment that the dying phase is recognized. The observations will end at death of when the primary endpoint is met. The care pathway is adapted for clinical research and includes extra observations by and questions to the nursing team.
After three months a questionnaire will be sent to the relatives.
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. H.J. (Jet) van Esch
- CONTACT for SCIENTIFIC QUERIESProf. Dr. S. Sleijfer
- Sponsor/Initiator Erasmus MC Cancer Institute, department of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- PublicationsIn 2019 and 2020 the results will be published.
- Brief summaryDeath rattle occurs in about half of the patients in the dying phase. Relatives often experience this as disturbing. Anticholinergics are recommended to treat death rattle, although there is no evidence for the effect of these drugs. Whereas anticholinergics do not affect existing mucus, it may be more effective when given preventively. We designed a study to test this hypothesis in patients admitted to a hospice.
The study will be conducted in four hospices in the Southwest region of the Netherlands.
Participating centers:
- Laurens Cadenza, Oosterhagen 239, 3078 CL, Rotterdam
- Hospice Calando, Vivaldilaan 2 C 4, 3247 EE Dirksland
- Hospice de Regenboog, Oudedijk 11, 3062 AB Rotterdam
- Stichting Curamus, hospice de Meander, Truffinoweg 2, 4561 NT Hulst
- Main changes (audit trail)
- RECORD24-apr-2017 - 29-jun-2017


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