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Decline in renal concentration ability in lithium treated patients

Recruiting
Conditions
lithium-induced nephrogenic diabetes insipidus
excessive
10029149
Registration Number
NL-OMON50138
Lead Sponsor
Radboud Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
51
Inclusion Criteria

o included in the previous study
o men and women
o 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:
- hypokalemia (plasma potassium < 3.5 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)
- instable angina pectoris
- decompensated cardial insufficiency
other:
- concomitant treatment with desmopressin or democlocycline

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Maximal urinary osmolality after intranasal administration of dDAVP.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- To determine the correlation between changes in kidney function and renal<br /><br>concentration ability<br /><br>- To determine the number of patients with chronic kidney disease<br /><br>- To determine the relation of the dDAVP test results with complaints<br /><br>(micturition history) and clinical parameters (duration of lithium therapy,<br /><br>plasma lithium concentration, baseline plasma creatinine, sodium and potassium<br /><br>concentration and baseline urinary osmolality) of lithium treated patients.<br /><br>- To determine the correlation between renal concentration ability and clinical<br /><br>parameters (duration of lithium therapy, plasma lithium concentration, baseline<br /><br>plasma creatinine, sodium and potassium concentration and baseline urinary<br /><br>osmolality) </p><br>
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