Terminal illness, terminal phase, advanced disease, dying phase, end-of-life care, refractory symptoms Terminal phase
Conditions
Interventions
Midazolam will be administered as part of routine care and is therefore not regarded as a research intervention within the scope of this study. Doses administered and treatment duration will vary, as
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Advance informed consent phase – hospice:Admitted to the hospice, with the expectation of remaining there until death Capable of providing informed consent (i.e., the patient is mentally competent and has sufficient decisional capacity, as assessed by the local physician or nurse specialist)Age = 18 yearsAdvance informed consent phase – Erasmus MC:Admitted to the medical oncology ward with a realistic likelihood of dying during the hospital stayCapable of providing informed consent (i.e., the patient is mentally competent and has sufficient decisional capacity, as assessed by the local physician or nurse specialist)Age = 18 yearsFinal inclusion phase (hospice and Erasmus MC):Administration of midazolam for palliative sedation, defined as either of the following: Intermittent palliative sedation, in which midazolam is administered either continuously for short periods or through repeated bolus injectionsContinuous palliative sedation, in which midazolam is administered continuously until death
Exclusion criteria
Exclusion criteria: Withdrawal of informed consent Unable to give (advance) informed consent, as assessed by the local physician or nurse specialist Age <18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Covariates, e.g., regarding co-medication, medication history, substance use (e.g., tobacco, alcohol), (co-)morbidity, laboratory results (such as albumin, liver enzymes, bilirubin, CRP, creatinine), CYP3A activity, nutritional status (intake, BMI, cachexia), and demographics (age, sex) that affect the PD of midazolam in CPS and therefore provide a basis for dose optimization and individualization. Validated observation instruments and routine clinical assessments will be used to monitor clinical effects and estimate PD parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Covariates that affect the PK of midazolamSuspected adverse events (e.g., respiratory suppression, paradoxical reactions)The use of levomepromazine in addition to midazolam Experiences of nurses with conducting research during the terminal phase of patients (qualitative interviews) | — |
Countries
Netherlands
Contacts
Public ContactE.C.T. Geijteman
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed