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The effect of acetazolamide on lithium-induced nephrogenic diabetes insipidus in patients with an affective disorder: a pilot study

Phase 2
Completed
Conditions
excessive urine production due to a diminished concentrating ability of the kidney as a result of the use of lithium
lithium-induced nephrogenic diabetes insipidus
10038430
Registration Number
NL-OMON35668
Lead Sponsor
niversitair Medisch Centrum Sint Radboud
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
6
Inclusion Criteria

sex: men and women
age: 18 years and older
stable patients treated with lithium for an affective disorder
moderate to severe lithium-induced nephrogenic diabetes insipidus (max. urinary osmolality >150 and <600 mOsm/kg)

Exclusion Criteria

pregnancy
diabetes mellitus
underlying renal disorders
significant cardiac/pulmonary comorbidity
heart rhythm disorders
pre-existent side effects of lithium treatment
treatment with hydrochlorothiazide or amiloride in the preceding 2 weeks
concomittant 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
NameTimeMethod
<p>Primary study parameters:<br /><br>- maximal urine volume reduction after stimulation with dDAVP<br /><br>- maximal urine osmolality after stimulation with dDAVP<br /><br>Both parameters will be evaluated 7 days before and 28 days after the start of<br /><br>treatment with acetazolamide. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary study parameters:<br /><br>- subjective symptoms (frequency of micturition)<br /><br>- vital signs (body weight and blood pressure)<br /><br>- blood levels of sodium, potassium, chloride, bicarbonate, lithium,<br /><br>creatinine, haemoglobin and osmolality-<br /><br>- urine levels of sodium, potassium, osmolality, urea and creatinine in morning<br /><br>spot urine samples<br /><br>- side effects of acetazolamide treatment<br /><br>- psychiatric outcome<br /><br>All parameters will be evaluated 7 days before and on day 0, 7, 14, 21, 28 and<br /><br>42 after the start of treatment with acetazolamide. </p><br>
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