Efficacy of hydroxyethyl starch (HES) 130/0.4 versus glucose solution in haemodilution therapy of idiopathic sudden hearing loss: a dose-finding, double-blind multicentre trial
Completed
- Conditions
- Sudden hearing lossEar, Nose and Throat
- Registration Number
- ISRCTN26222607
- Lead Sponsor
- Fresenius Kabi Deutschland GmbH (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 210
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
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Efficacy:<br>1. AHG at other timepoints (i.e. Days 3, 14, and 90)<br>2. AHG based on geometric MAHT<br>3. Hearing gain based on the Schwab/Ewert formula i.e. the arithmetic mean of the delogarithmed pure tone thresholds<br>4. AHG based on arithmetic and geometric MAHT calculated only on speech frequencies with an initial hearing loss of 20 dB or more<br>5. Outcome categorised in complete/partial/no recovery or deterioration<br>6. Changes of subjective hearing, vertigo, and tinnitus<br><br>Safety:<br>1. Adverse events<br>2. Laboratory parameters (haematology, haemostasis, clinical chemistry, urinalysis)<br>3. Vital signs