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

ISRCTN	ISRCTN26222607
DOI	https://doi.org/10.1186/ISRCTN26222607
Protocol serial number	HS-13-26-EU
Sponsor	Fresenius Kabi Deutschland GmbH (Germany)
Funder	Fresenius Kabi Deutschland GmbH (Germany) (ref: HS-13-26-EU)

Submission date: 03/02/2005
Registration date: 09/02/2005
Last edited: 18/02/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Eckart Klemm
Scientific

HNO-Klinik Krankenhaus Dresden-Friedrichstadt
Friedrichstr. 41
Dresden
01067
Germany

Phone	+49 (0)351 480 1220
Email	Raehder-Co@khdf.de

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Hydroxyethyl starch
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	210
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/11/2000
Date of final enrolment	31/12/2002

Locations

Countries of recruitment

Germany

Study participating centre

HNO-Klinik Krankenhaus Dresden-Friedrichstadt

Dresden
01067
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan