Hearing StatusNCT00945386
The Effect of Continuous, Various Doses of Furosemide Drip on Hearing as Measured by Acoustic Emission
An observational study of Hearing Status, run by Rabin Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Hearing Status
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2009to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: critically ill children in pediatric ICU.
Who may be able to join
- All children admitted to Pediatric ICU who are treated with furosemide continuous drip.
Who cannot join
- Children with known hearing abnormalities prior to treatment.
Trial locations and contacts
1 site in 1 country.
Miriam Davidowitz, MD contact
Israel1 site
Pediatric ICU, Schneider Children's Hospital
Petah Tikva, 49202
elhanan Nahum, MD, 97239253686, enahum@clalit.org.il
Gili Kadmon, MD, 97239253686, gkadmon@clalit.org.il
About this study
Official title: The Effect of Continuous, Various Dosages of Furosemide Drip on Hearing as Measured by Acoustic Emission
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.
Read the 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.
- Conditions
- Hearing Status
- Keywords
- children, critically ill, furosemide, acoustic emission
- Medical subject headings
- Critical Illness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startAug 2009
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Elhanan Nahum, MD, Study director, Schneider Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945386
- Sponsor's protocol ID
- 005418
- Status last verified
- Jul 2009
- First submitted
- 23 Jul 2009
- Last updated
- 24 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous, Various Dosages of Furosemide Drip on Hearing as Measured by Acoustic Emission
- ClinicalTrials.gov ID
- NCT00945386
- Acronym / sponsor ID
- 005418
- Conditions
- Hearing Status
- Keywords
- children, critically ill, furosemide, acoustic emission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Aug 2009
- Study completion
- Aug 2010 (estimated)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- critically ill children in pediatric ICU.
Key inclusion criteria (1 listed)
- All children admitted to Pediatric ICU who are treated with furosemide continuous drip.
Key exclusion criteria (1 listed)
- Children with known hearing abnormalities prior to treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam Davidowitz, MD contact
Elhanan Nahum, MD study director
Schneider Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Status, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elhanan - Nahum, MD (972 3 9253686, enahum@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2009.