Acetazolamide (AZ) for Management of Alkalosis in Bartter Syndrome

Bartter Syndrome Clinical Trial

— AZ  

Official title:

Acetazolamide (AZ) for Management of Refractory Hypokalemia Metabolic Alkalosis in Bartter Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03847571
• Other study ID #: Acetazolamide (AZ)
• Status: Recruiting
• Start date: January 10, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2019
• Source: Tehran University of Medical Sciences
• Contact: Farahnak Assadi, MD
• Phone: 3125600477
• Email: fassadi[@]rush.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this prospective controlled cross over clinical trial, the investigators aim to evaluate the efficacy and safety of acetazolamide for the management of metabolic alkalosis in children with Bartter syndrome. Urine and blood electrolytes will be measured before and after acetazolamide treatment. The primary end point is a change in polyuria, hypokalemia, and metabolic alkalosis.

Description:

Bartter syndrome is a hereditary salt-loosing tubulopathy caused by several gene mutations encoding the sodium reabsorption in the thick ascending limb of loop of Henle, with poor response to treatment. The effects of inhibition of proximal tubular reabsorption of bicarbonate by acetazolamide have not been previously studied in Batter patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

Inclusion Criteria:

• Hypokalemia

• metabolic alkalosis

• normal blood pressure

• random urine chloride >20 milliequivalent per liter (mEq/L)

• Elevated serum aldosterone and renin levels

Exclusion Criteria:

• Hypertension

• History of emesis

• Prior use of laxatives

• Cystic fibrosis ofpancrease

Related Conditions & MeSH terms

• Alkalosis
• Bartter Syndrome
• Syndrome

Intervention

Drug:
• Acetazolamide
Correction of metabolic alkalosis by inhibition of the filtered bicarbonate load reabsorption in the proximal tubules using acetazolamide (AZ)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Fateme Ghane Sharbaf	Mashhad
Iran, Islamic Republic of	Semnan University of Medical Sciences	Semnan
Iran, Islamic Republic of	Banafshe Dormansh	Tehran
Iran, Islamic Republic of	Simin Sadeghi	Zahedan

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic alkalosis	Change in serum bicarbonate level	4 weeks
Primary	Urine output	Change in 24-hr urine volume	4 weeks