Clinical trial NCT03248856: Triamcinolone Levels in Cochlear Perilymph
Official title: Triamcinolone Levels in Cochlear Perilymph
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cochlear Hearing Loss
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Triamcinolone levels in comparison
timeFrame: 2 years
Secondary outcomes:
measure: Triamcinolone stability
timeFrame: 2 years
measure: Triamcinolone concentrations
timeFrame: 2 years
measure: Impedances
timeFrame: 2 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna (AKH)
Study officials:
References:
citation: Dahm V, Gausterer JC, Auinger AB, Honeder C, Gabor F, Reznicek G, Kaider A, Riss D, Arnoldner C. Evaluation of Levels of Triamcinolone Acetonide in Human Perilymph and Plasma After Intratympanic Application in Patients Receiving Cochlear Implants: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Nov 1;147(11):974-980. doi: 10.1001/jamaoto.2021.2492.