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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00945386
Other study ID # 005418
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 23, 2009
Last updated July 23, 2009
Start date August 2009
Est. completion date August 2010

Study information

Verified date July 2009
Source Rabin Medical Center
Contact Elhanan - Nahum, MD
Phone 972 3 9253686
Email enahum@clalit.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 18 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Pediatric ICU, Schneider Children's Hospital Petah Tikva

Sponsors (1)

Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel,