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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00945386
Recruitment Status : Unknown
Verified July 2009 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 24, 2009
Last Update Posted : July 24, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease
Hearing Status

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.


Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Continuous, Various Dosages of Furosemide Drip on Hearing as Measured by Acoustic Emission
Study Start Date : August 2009
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945386


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

Locations
Israel
Pediatric ICU, Schneider Children's Hospital Not yet recruiting
Petah Tikva, Israel, 49202
Contact: elhanan Nahum, MD    97239253686    enahum@clalit.org.il   
Contact: Gili Kadmon, MD    97239253686    gkadmon@clalit.org.il   
Principal Investigator: Elhanan Nahum, MD         
Principal Investigator: Miriam Dawidowitz, MD         
Sub-Investigator: Gili Kadmon, MD         
Sub-Investigator: Offer Schiller, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Study Director: Elhanan Nahum, MD Schneider Children's Hospital
More Information

Responsible Party: Dr. Elhanan Nahum, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00945386     History of Changes
Other Study ID Numbers: 005418
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: July 24, 2009
Last Verified: July 2009

Keywords provided by Rabin Medical Center:
children
critically ill
furosemide
acoustic emission

Additional relevant MeSH terms:
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action