Impact on the Absorption of Drugs in Ostomy Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWiGeV Klinik Ottakring

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Ileostomy and colostomy patients undergoing inpatient/outpatient treatment at Klinik Ottakring

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Monitoring

    Diagnostic test

    Monitoring

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Achieved therapeutic serum levels in ostomy patients compared with the therapeutic ranges of the respective pivotal study

During a routine blood draw, an additional 2ml (Psychotropic drugs: citalopram, clozapine, duloxetine, escitalopram, melperone, mianserin, milnacipran, mirtazapine, olanzapine, paliperidone, paroxetine, pregabalin, prothipendyl, quetiapine, risperidone, sertraline, trazodone, venlafaxine)or 3.5 ml (NOACs: edoxaban, rivaroxban, apixaban)of blood is taken. In this sample, the drug levels are determined using a validated method ( LC-MS/MS (Psychotropic drugs) or chromogenic test (NOACs)). The drug level \[µg/ml\] determined in this way is compared with the therapeutic target range specified in the respective approval studies.

Time frame
18 month

Secondary outcomes

Other outcomes

Sponsors and contacts

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