Acetazolamide (AZ) for Management of Alkalosis in Bartter Syndrome

NCT ID: NCT03847571

Last Updated: 2019-02-20

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-10

Study Completion Date

2019-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bartter Syndrome

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Acetazolamide

Oral administration of acetazolamide 5 mg/kg/day for 4 weeks

Acetazolamide

Intervention Type DRUG

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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Semnan University of Medical Sciences

Semnan, , Iran

Site Status RECRUITING

Banafshe Dormansh

Tehran, , Iran

Site Status NOT_YET_RECRUITING

Simin Sadeghi

Zahedan, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Farahnak Assadi, MD

Role: CONTACT

3125600477

Mojgan Mazaheri, MD

Role: CONTACT

00-98 9123069789

Facility Contacts

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Fateme Ghane Sharbaf, MD

Role: primary

00 98 9153112139

Farahnak Assadi

Role: backup

3125600477

Mojgan Mazaheri, MD

Role: primary

9123069789

Farahnak Assadi, MD

Role: backup

3125600477

Banafshe Dormanesh, MD

Role: primary

00 98 9123886725

Farahnak Assadi, MD

Role: backup

3125600477

Simin Sadeghi, MD

Role: primary

00 98 54533295573

Farahnak Assadi, MD

Role: backup

3125600477

Other Identifiers

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Acetazolamide (AZ)

Identifier Type: -

Identifier Source: org_study_id

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