The effect of the drug acetazolamide on excessive urine production due to a diminished concentrating ability of the kidney as a result of the use of lithium in patients with an affective disorder: a pilot study

Conditions: lithium-induced nephrogenic diabetes insipidus
MedDRA version: 14.1Level: LLTClassification code 10012600Term: Diabetes insipidus nephrogenicSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1Level: LLTClassification code 10050501Term: Lithium toxicitySystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-005970-41-NL

Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the effect of acetazolamide on lithium-induced nephrogenic diabetes insipidus measured as urine volume and maximal urinary osmolality. <br>;Secondary Objective: To explore the possible changes in subjective symptoms (frequency of micturition); vital signs (body weight and blood pressure); blood levels of sodium, potassium, chloride, bicarbonate, lithium, creatinine, haemoglobin and osmolality; urine levels of sodium, potassium, osmolality, urea and creatinine in morning spot urine samples; side effects of acetazolamide treatment; and psychiatric outcome.<br>;Primary end point(s): urine volume and maximal urinary osmolality after dDAVP administration<br>;Timepoint(s) of evaluation of this end point: urine volume:<br>- daily (questionnaire)<br>- day -7, 0, 7, 14, 21, 28 and 42 (24 h urine collection)<br><br>maximal urinary osmolality after dDAVP administration:<br>- day -7 and 28 (before and during treatment with acetazolamide)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): changes in subjective symptoms (frequency of micturition); vital signs (body weight and blood pressure); blood levels of sodium, potassium, chloride, bicarbonate, lithium, creatinine, haemoglobin and osmolality; urine levels of sodium, potassium, osmolality, urea and creatinine in morning spot urine samples; side effects of acetazolamide treatment; and psychiatric outcome.;Timepoint(s) of evaluation of this end point: All above mentioned items:<br>- day -7, 0, 7, 14, 21, 28 and 42