Acetazolamide (AZ) for Management of Alkalosis in Bartter Syndrome
NCT ID: NCT03847571
Last Updated: 2019-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2019-01-10
2019-12-30
Brief Summary
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Detailed Description
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The present study is designed to assess he efficacy and safety of acetazolamide for the management of children with Bartter syndrome. The primary end point is change in polyuria, hypokalemia, and metabolic alkalosis.
In this prospective observational crossover clinical trial, patients between ages 1 and 10 years with clinical diagnosis of Bartter syndrome (hypokalemia, metabolic alkalosis, normal blood pressure, elevated urine chloride \>20 milliequivalent per liter, high serum aldosterone and plasma renin levels) will be enrolled in a 4- week clinical trial. After initial clinical and laboratory evaluations, patients will receive acetazolamide 5.0 mg/kg orally as a single daily dose and each patient will act as his/her own control. Renal electrolyte and 24-hour urine output will be measured at baseline and after the 4 weeks acetazolamide treatment.
Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Acetazolamide
Oral administration of acetazolamide 5 mg/kg/day for 4 weeks
Acetazolamide
Correction of metabolic alkalosis by inhibition of the filtered bicarbonate load reabsorption in the proximal tubules using acetazolamide (AZ)
Interventions
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Acetazolamide
Correction of metabolic alkalosis by inhibition of the filtered bicarbonate load reabsorption in the proximal tubules using acetazolamide (AZ)
Eligibility Criteria
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Inclusion Criteria
* metabolic alkalosis
* normal blood pressure
* random urine chloride \>20 milliequivalent per liter (mEq/L)
* Elevated serum aldosterone and renin levels
Exclusion Criteria
* History of emesis
* Prior use of laxatives
* Cystic fibrosis ofpancrease
1 Year
10 Years
ALL
No
Sponsors
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Tehran University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Farahnak Assadi, MD
Role: STUDY_DIRECTOR
Rush University Medical Center
Locations
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Fateme Ghane Sharbaf
Mashhad, , Iran
Semnan University of Medical Sciences
Semnan, , Iran
Banafshe Dormansh
Tehran, , Iran
Simin Sadeghi
Zahedan, , Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Acetazolamide (AZ)
Identifier Type: -
Identifier Source: org_study_id
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