Contact information
Type
Scientific
Primary contact
Prof Eckart Klemm
ORCID ID
Contact details
HNO-Klinik Krankenhaus Dresden-Friedrichstadt
Friedrichstr. 41
Dresden
01067
Germany
+49 (0)351 480 1220
Raehder-Co@khdf.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HS-13-26-EU
Study information
Scientific title
Acronym
Study hypothesis
Objective: Obtain first data on HES 130/0.4 (hydroxyethyl starch) as monotherapy in patients with acute idiopathic sudden sensorineural hearing loss (ISSNHL).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Sudden hearing loss
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Hydroxyethyl starch
Primary outcome measures
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
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
Overall trial start date
01/11/2000
Overall trial end date
31/12/2002
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
210
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2000
Recruitment end date
31/12/2002
Locations
Countries of recruitment
Germany
Trial participating centre
HNO-Klinik Krankenhaus Dresden-Friedrichstadt
Dresden
01067
Germany
Sponsor information
Organisation
Fresenius Kabi Deutschland GmbH (Germany)
Sponsor details
Else Kröner Str. 1
Bad Homburg v.d.H
61352
Germany
+49 (0)6172 686 7324
Daniela.Baus@fresenius-kabi.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Fresenius Kabi Deutschland GmbH (Germany) (ref: HS-13-26-EU)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary