Impact on the Absorption of Drugs in Ostomy Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Monitoring.
- Who it may be relevant to
- Registry conditions: Stoma Ileostomy, Ileostomy - Stoma, Colostomy - Stoma, Absorption. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Beeinflussung Der Resorption Von Arzneimitteln Bei Stoma Patient*Innen
Overview
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.
Interventions
- Diagnostic test Monitoring
Monitoring
Primary outcome measures
- Achieved therapeutic serum levels in ostomy patients compared with the therapeutic ranges of the respective pivotal study [Time frame: 18 month]
Eligibility criteria
Planned inclusion criteria:
- 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
Exclusion criteria
Insurmountable language barrier
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- WiGeV Klinik Ottakring — Vienna
Identifiers
NCT: NCT07138326 · EK25008