Triamcinolone Levels in Cochlear Perilymph

Sponsor

Christoph Arnoldner (Other)

Overall Status

Completed

CT.gov ID

NCT03248856

Collaborator

(none)

Enrollment

Location

Arms

43.9

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cochlear Hearing Loss	Drug: Triamcinolone Acetonide	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Triamcinolone Levels in Cochlear Perilymph

Actual Study Start Date :

Oct 2, 2017

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Group 1 Group 1 will receive triamcinolone acetonide 10mg 20 to 24hours before sampling.	Drug: Triamcinolone Acetonide Intratympanic administration
Other: Group 2 Group 2 will receive triamcinolone acetonide 40mg 20 to 24hours before sampling.	Drug: Triamcinolone Acetonide Intratympanic administration
Other: Group 3 Group 3 will receive triamcinolone acetonide 10mg 1 to 2 hours before sampling.	Drug: Triamcinolone Acetonide Intratympanic administration
Other: Group 4 Group 3 will receive triamcinolone acetonide 40mg 1 to 2 hours before sampling.	Drug: Triamcinolone Acetonide Intratympanic administration

Outcome Measures

Primary Outcome Measures

Triamcinolone levels in comparison [2 years]
Absorption of Triamcinolone acetonide in cochlear perilymph in comparison to dissemination to the blood circulation

Secondary Outcome Measures

Triamcinolone stability [2 years]
The stability of triamcinolone acetonide levels in the cochlear perilymph
Triamcinolone concentrations [2 years]
Perilymph concentrations and blood concentrations of triamcinolone acetonide after administration of different Triamcinolone acetonide doses.
Impedances [2 years]
Difference of impedances of patients receiving different doses at different timepoints

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna (AKH)	Vienna		Austria	1090

Sponsors and Collaborators

Christoph Arnoldner

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christoph Arnoldner, Assoc Prof PD Dr., Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT03248856

Other Study ID Numbers:

1456/2017
2017-002377-19

First Posted:

Aug 14, 2017

Last Update Posted:

Sep 28, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Hearing Loss

Hearing Loss, Sensorineural

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Study Results

No Results Posted as of Sep 28, 2021