The Effect of Continuous, Various Doses of Furosemide Drip on Hearing as Measured by Acoustic Emission

This study is not yet open for participant recruitment.

Verified by Rabin Medical Center, July 2009

First Received: July 23, 2009 No Changes Posted

Sponsor:	Rabin Medical Center
Information provided by:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00945386

Purpose

Pediatric patients, during their illness often treated with furosemide (Lasix) continuous drip, often, with dosages above 4-6mg/kg/day (the recommended dose).

This study will monitor hearing status of these children prior to their therapy with furosemide, during this therapy and after.

Condition
Hearing Status

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	The Effect of Continuous, Various Dosages of Furosemide Drip on Hearing as Measured by Acoustic Emission

Resource links provided by NLM:

Drug Information available for: Furosemide

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	August 2009
Estimated Study Completion Date:	August 2010

Detailed Description:

This study will record hearing status, by acoustic emission, of critically ill children, treated with different dosages of furosemide drip.

Acoustic emission test will be done prior to therapy and q48 hours during their course of treatment with furosemide drip.

Dosage of furosemide drip, boluses and other relevant medications (i.e - vancomycin, muscular relaxants, aminoglycosides etc) will be recorded.

Eligibility

Ages Eligible for Study:	1 Month to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

critically ill children in pediatric ICU.

Criteria

Inclusion Criteria:

All children admitted to Pediatric ICU who are treated with furosemide continuous drip.

Exclusion Criteria:

Children with known hearing abnormalities prior to treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945386

Contacts

Contact: Elhanan - Nahum, MD	972 3 9253686 ext -	enahum@clalit.org.il
Contact: Miriam Davidowitz, MD	972 3 7253666

Locations

Israel
Pediatric ICU, Schneider Children's Hospital
Petah Tikva, Israel, 49202

Sponsors and Collaborators

Rabin Medical Center

Investigators

Study Director:

Elhanan Nahum, MD

Schneider Children's Hospital

More Information

No publications provided

Responsible Party:	Rabin Medical Center ( Dr. Elhanan Nahum )
Study ID Numbers:	005418
Study First Received:	July 23, 2009
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00945386 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Rabin Medical Center:

children
critically ill
furosemide
acoustic emission

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs

Diuretics
Cardiovascular Agents
Sodium Potassium Chloride Symporter Inhibitors
Furosemide
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010