lithium-induced nephrogenic diabetes insipidus MedDRA version: 14.1 Level: LLT Classification code 10012600 Term: Diabetes insipidus nephrogenic System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1 Level: LLT Classification code 10050501 Term: Lithium toxicity System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: Acetazolamide Sandoz 250
Pharmaceutical Form: Tablet
CAS Number: 59-66-5
Other descriptive name: ACETAZOLAMIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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: - day -7, 0, 7, 14, 21, 28 and 42 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of acetazolamide on lithium-induced nephrogenic diabetes insipidus measured as urine volume and maximal urinary osmolality. ;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. ;Primary end point(s): urine volume and maximal urinary osmolality after dDAVP administration ;Timepoint(s) of evaluation of this end point: urine volume: - daily (questionnaire) - day -7, 0, 7, 14, 21, 28 and 42 (24 h urine collection) maximal urinary osmolality after dDAVP administration: - day -7 and 28 (before and during treatment with acetazolamide) | — |
Countries
Netherlands
Contacts
Public ContactAcetazolamide - pilot study
Radboud University Nijmegen Medical Centre
Outcome results
None listed