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
Secondary identifying numbers 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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesObjective: 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) studiedSudden hearing loss
InterventionInfusion 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Hydroxyethyl starch
Primary outcome measureAbsolute 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 measuresEfficacy:
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 study start date01/11/2000
Completion date31/12/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants210
Key inclusion criteria210 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 criteriaNot provided at time of registration
Date of first enrolment01/11/2000
Date of final enrolment31/12/2002

Locations

Countries of recruitment

  • Germany

Study participating centre

HNO-Klinik Krankenhaus Dresden-Friedrichstadt
Dresden
01067
Germany

Sponsor information

Fresenius Kabi Deutschland GmbH (Germany)
Industry

Else Kröner Str. 1
Bad Homburg v.d.H
61352
Germany

+49 (0)6172 686 7324
Daniela.Baus@fresenius-kabi.com
ROR logo https://ror.org/01v376g59

Funders

Funder type

Industry

Fresenius Kabi Deutschland GmbH (Germany) (ref: HS-13-26-EU)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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