Triamcinolone Levels in Cochlear Perilymph

Cochlear Hearing Loss Clinical Trial

Official title:

Triamcinolone Levels in Cochlear Perilymph

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248856
• Other study ID #: 1456/2017
• Secondary ID: 2017-002377-19
• Status: Completed
• Phase: Phase 1
• Start date: October 2, 2017
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2021
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study Triamcinolone acetonide will be applied intratympanically before cochlear implant surgery. After round window exposure, a perilymph sample and simultaneously a blood sample will be drawn. Triamcinolone levels will then be analyzed in the samples.

Description:

At the ENT department of the university hospital Vienna (AKH Wien) patients are treated with intratympanic triamcinolone acetonide before cochlea implantation to reduce inflammation and in some cases to protect residual hearing. Triamcinolone acetonide levels in cochlear perilymph will be evaluated in an open prospective clinical study. Patients scheduled for cochlear implant surgery between 18 and 90 years will be included. Patients who are treated with steroids preoperatively will be excluded from the study. Patients will be randomized after inclusion to one of four groups. The randomization is carried out to generate hypothesis for the needed dose and best time of application in the future. Triamcinolone acetonide will then be applied 20-24h before surgery or at the beginning of the surgery, depending on randomization (see below). About 20 µl of perilymph will be sampled simultaneously to a blood sample during cochlear implant surgery.

The probes will be stored at -80°C. Triamcinolone acetonide levels of the blood and perilymph will be determined by the pharmaceutical laboratory (Department of Pharmaceutical Technology and Biopharmaceutics, University of Vienna).

The patients will be randomized to 4 groups. Group 1 - Volon A 10mg administration 20 - 24 hours before sampling. Group 2 - Volon A 40mg administration 20 - 24 hours before sampling. Group 3 Volon A 10mg - administration 1 to 2 hours before sampling. Group 4 - Volon A 40mg administration 1 to 2 hours before sampling.

The time interval of application (1 to 2 hours and 20 to 24 hours before sampling) are a result of varying time of surgery depending on surgeons and patient anatomy as well as day to day clinical organization. Patients can withdraw consent at any time of the study.

The active phase of each patient will be between 6 and 9 days depending on time of follow-up visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients between 18 and 90 years will be included in the study, who will undergo a cochlear implantation and are willing to participate in the study

Exclusion Criteria:

• Patients younger than 18 years

• Patients who receive cortisone on a regular basis or receive cortisone i.v. or p.o. preoperatively

• Patients with contraindications against the administration of Volon A

Related Conditions & MeSH terms

• Cochlear Hearing Loss
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Drug:
• Triamcinolone Acetonide
Intratympanic administration

Locations

Country	Name	City	State
Austria	Medical University of Vienna (AKH)	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Christoph Arnoldner

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triamcinolone levels in comparison	Absorption of Triamcinolone acetonide in cochlear perilymph in comparison to dissemination to the blood circulation	2 years
Secondary	Triamcinolone stability	The stability of triamcinolone acetonide levels in the cochlear perilymph	2 years
Secondary	Triamcinolone concentrations	Perilymph concentrations and blood concentrations of triamcinolone acetonide after administration of different Triamcinolone acetonide doses.	2 years
Secondary	Impedances	Difference of impedances of patients receiving different doses at different timepoints	2 years