Beeinflussung Der Resorption Von Arzneimitteln Bei Stoma Patient*Innen

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

Peroral administration is the preferred way of taking medication. However, the special absorption conditions in ostomy patients are generally not addressed in approval studies and there is also little other literature on this topic. These are usually case reports or studies on individual patients or very small patient collectives. For medications with measurable clinical parameters, e.g. blood pressure, blood sugar, etc: Blood pressure, blood sugar, etc., these can be used to draw conclusions about any absorption problems. For medications without the possibility of a direct and objective assessment, the assessment is difficult due to the very low level of evidence. Drug groups without a direct physiological measure are e.g: Psy-chotropic drugs (antipsychotics, antidepressants, anxiolytics) and also the novel oral anticoagulants (NOACs). The clinical trial´s results will answer the following questions: * Are therapeutic blood levels of psychotropic drugs and NOACs achieved in ostomy patients when taken orally in the usual way? * Are there differences between the measured levels of ileostomy and colostomy patients? Colostomy and ileostomy patients undergoing inpatient or outpatient treatment at the Klinik Ottakring are ready for inclusion. The blood samples will be obtained during medically indicated and performed blood draws within the scope of medical practice, so that no study-associated risks arise here. Recorded and evaluated: * Relevant patient data * Plasma levels of the drugs under investigation in ostomy patients. The therapeutic range specified in the respective approval studies serves as the reference value. The results obtained are documented, evaluated and interpreted in an appropriate manner.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male and female patients aged ≥18 years

• Belonging to a collective

• Ileostomy since ≥7d

• Colostomy since ≥7d The stoma must have been inserted at least 7d ago to ensure that a steady state concentration is achieved.

• Taking ≥1 of the following active substances since ≥7d:

‣ Psychotropic drugs: citalopram, clozapine, duloxetine, escitalopram, melperone, mianserin, milnacipran, mirtazapine, olanzapine, paliperidone, paroxetine, pregabalin, prothipendyl, quetiapine, risperidone, sertraline, trazodone, venlafaxine

⁃ NOACs: edoxaban, rivaroxban, apixaban

Locations
Other Locations
Austria
WiGeV Klinik Ottakring
RECRUITING
Vienna
Contact Information
Primary
Irene Lagoja, Dr
irene.lagoja@gesundheitsverbund.at
+431491505508
Backup
Stefanie Hehenberger, Mag
stefanie.hehenberger@gesundheitsverbund.at
+431491505508
Time Frame
Start Date: 2025-06-18
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 128
Related Therapeutic Areas
Sponsors
Leads: WiGeV Klinik Ottakring

This content was sourced from clinicaltrials.gov