the pharmaprofile; towards tailor-made pharmacotherapy for the terminally ill adult patient.

Recruiting

• Conditions: palliatieve zorg, terminale ziekte; comfort; palliative sedation

• Registration Number: NL-OMON34339
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

-Terminal illness
-Prognosis survival more than 2 days and less than 3 months
-Administration of morphine, haloperidol and/or midazolam
-Informed consent

Exclusion Criteria

-Withdrawal of informed consent
-No blood sample obtained

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The development of a population pharmacokinetic-pharmacodynamic model for<br /><br>morphine, haloperidol and midazolam for terminally ill patients. For each<br /><br>patient a pharmaprofile will be constructed contain information regarding<br /><br>co-morbidity, co-medication, nutritional status, laboratory results,<br /><br>demographic and pathophysiological factors.<br /><br>Pharmacokinetics parameters will be estimated in small samples of blood and<br /><br>urine using the LC-MS technique and analysis by NONMEM-software. NONMEM allows<br /><br>the use of limited numbers of samples/observations and sparse sampling<br /><br>strategies without fixed protocol times.<br /><br>Clinical responses will be monitored with objective and validated instruments<br /><br>for pain, confusion, sedation, nausea/vomiting, dyspnoea and fatigue to<br /><br>estimate pharmacodynamic parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>