A diminished concentrating ability of the kidneys due to lithium prescription: how many and whom is affected?

Conditions: Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
lithium-induced urinary concentrating defects (nephrogenic diabetes insipidus)
MedDRA version: 15.0Level: LLTClassification code 10012600Term: Diabetes insipidus nephrogenicSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 15.0Level: LLTClassification code 10050501Term: Lithium toxicitySystem Organ Class: 10022117 - Injury, poisoning and procedural complications

Registration Number: EUCTR2012-001809-24-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

?stable patients with a mood disorder treated with lithium
?men and women
?age = 18 years
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

?general contra-indications for participation in a trial:
oinability to give informed consent
opregnancy
ounstable psychiatric condition

?alternative causes of (nephrogenic) diabetes insipidus:
ohypo/hyperkalemia (plasma potassium < 3.5 or > 5.5 mmol/l)
osevere hypercalcemia (albumin-corrected plasma calcium > 2.80 mmol/l)
ohyperglycemia (plasma glucose > 10.0 mmol/l)
ohistory of amyloidosis, Sjögren’s syndrome or Sickle cell anemia
oprevious treatment with ifosfamide
oestablished primary polydipsia or central diabetes insipidus

?contra-indications for dDAVP administration:
oinability to comply with water restriction
orenal insufficiency (GFR < 45 ml/min/1.73 m2)
ohyponatremia (plasma sodium < 130 mmol/l

?other:
oconcomitant treatment with desmopressin or democlocycline

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to explore the prevalence of urinary concentrating defects in a Dutch population of lithium treated patients;Secondary Objective: to determine the relation of the dDAVP test results with complaints (micturition history) and clinical parameters (duration of lithium therapy, plasma lithium concentration, baseline plasma creatinine, sodium and potassium concentration and baseline urinary osmolality) of lithium treated patients;Primary end point(s): maximal renal concentrating ability determined by measuring urine osmolality after intranasal administration of dDAVP 40 micrograms;Timepoint(s) of evaluation of this end point: after intranasal administration of dDAVP 40 micrograms, urine will be collected by voluntary voiding for measuring urine osmolality every 60-120 minutes for a total duration of 6 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): the relation of the dDAVP test results with complaints (micturition history) and clinical parameters (duration of lithium therapy, plasma lithium concentration, baseline plasma creatinine, sodium and potassium concentration and baseline urinary osmolality) of lithium treated patients;Timepoint(s) of evaluation of this end point: once only