Evaluation of urinary concentrating defects in lithium treated patients with a dDAVP test

Recruiting

• Conditions: lithium-induced nephrogenic diabetes insipidus; excessive urine production due to an impaired concentrating ability of the kidneys as a result of the use of lithium; 10038430

• Registration Number: NL-OMON37665
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

stable patients with a mood disorder treated with lithium
men and women
age >= 18 years

Exclusion Criteria

general contra-indications for participation in a trial:
inability to give informed consent
pregnancy
unstable psychiatric condition;alternative causes of (nephrogenic) diabetes insipidus:
hypo/hyperkalemia (plasma potassium < 3.5 or > 5.5 mmol/l)
severe hypercalcemia (albumin-corrected plasma calcium > 2.80 mmol/l)
hyperglycemia (plasma glucose > 10.0 mmol/l)
history of amyloidosis, Sjögren*s syndrome or Sickle cell anemia
previous treatment with ifosfamide
established primary polydipsia or central diabetes insipidus;contra-indications for dDAVP administration:
inability to comply with water restriction
renal insufficiency (GFR < 45 ml/min/1.73 m2)
hyponatremia (plasma sodium < 130 mmol/l) ;other:
concomitant treatment with desmopressin or democlocycline

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Maximal urinary osmolality after intranasal administration of dDAVP.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Relation of the dDAVP test results with complaints (micturition history) and<br /><br>clinical parameters (duration of lithium therapy, plasma lithium concentration,<br /><br>baseline plasma creatinine, sodium and potassium concentration and baseline<br /><br>urinary osmolality). </p><br>