Sudden hearing loss Ear, Nose and Throat Sudden hearing loss
Conditions
Interventions
Infusion of 750 ml per day with HES 45 g per day (group H), 30 g per day (M), 15 g per day (L), or glucose 5% (G) acting as 'placebo' control over 6 days.
Sponsors
Fresenius Kabi Deutschland GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 210 inpatients with first-time idiopathic sudden sensorineural hearing loss (ISSNHL) of 20 dB or more at two or more frequencies and 95 dB or less at all of the speech frequencies (0.5, 1.0, 2.0, 3.0, 4.0 kHz) with respect to the other (normal) ear for up to 7 days.
Exclusion criteria
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute hearing gain (AHG) in decibel at Day 7, calculated as mean audiometric hearing threshold (MAHT) at baseline minus MAHT at Day 7, whereby MAHT was the arithmetic mean of the hearing thresholds in dB at the main speech frequencies of 0.5, 1, 2, 3, and 4 kilohertz | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1. AHG at other timepoints (i.e. Days 3, 14, and 90) 2. AHG based on geometric MAHT 3. Hearing gain based on the Schwab/Ewert formula i.e. the arithmetic mean of the delogarithmed pure tone thresholds 4. AHG based on arithmetic and geometric MAHT calculated only on speech frequencies with an initial hearing loss of 20 dB or more 5. Outcome categorised in complete/partial/no recovery or deterioration 6. Changes of subjective hearing, vertigo, and tinnitus Safety: 1. Adverse events 2. Laboratory parameters (haematology, haemostasis, clinical chemistry, urinalysis) 3. Vital signs | — |
Countries
Germany
Outcome results
None listed