Acetazolamide in lithium-induced nephrogenic diabetes insipidus (NDI).

Phase 3

• Conditions: ithium-induced nephrogenic diabetes insipidus; Lithium-induced nephrogenic diabetes insipidus; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12613000195752
• Lead Sponsor: Department of Medicine University of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

stable patients treated with lithium for an affective disorder
men and women
age > 18 years
evidence of lithium- induced nephrogenic diabetes insipidus

Exclusion Criteria

pregnancy
diabetes mellitus
underlying renal disorders
significant cardiac/pulmonary comorbidity
heart rhythm disorders
side effects of lithium treatment
treatment with hydrochlorothiazide or amiloride in the preceding 2 weeks
concomitant treatment with other diuretics
hypotension (systolic blood pressure < 100 mm Hg)
renal insufficiency
hypo/hyperkalemia
hypercalcaemia
hypo/hyperthyroidism

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A change in urinary concentrating ability.<br>This will measured by a standard water deprivation and urinary concentration test. Following an overnight fast, a baseline urine sample will be collected at 0830. Then 40ug desmopressin (dDAVP) will be administered intranasally. Urine samples will be collected at 2,4 and 6 hours to measure urine osmolality.<br>This will be done at baseline and at the end of 4 week.[at baseline and following 4 weeks of therapy.]

Secondary Outcome Measures

Name	Time	Method
Patients' reported fluid intake and urine output. <br>Clinical assessment at each visit.[At baseline and at each weekly visit for 4 weeks];Assessment of blood pressure. Clinical assessment at each weekly visit[At baseline and at each weekly vosit for 4 weeks];Assessment of renal function by routine weekly measurement of plasma creatinine[At baseline and weekly for 4 weeks];Assessment of plasma lithium concentrations by weekly blood tests.[At baseline and weekly for 4 weeks.]