Effect of amiloride on polyuria and well being in lithium treated patients

Withdrawn

Conditions: Diabetes Insipidus. Frequent urination
10026753
10029149

Registration Number: NL-OMON46002

Lead Sponsor: Maasstadziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet the following criteria:
-Participant did not experience polyuria before commencing lithium therapy.
-All participants are aged 18 years and over.
-24 hour urine volume>3L

Exclusion Criteria

-Inability to give informed consent
-Inability to complete overnight water deprivation test
-Patients aged under 18 years
-Pregnancy
-History of renal disease
-Usage of other diuretics that cannot be discontinued
-Presence of diabetes insipidus or other etiology
-Contraindications for amiloride therapy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main endpoint is the change in 24 hour urine volume after intervention with<br /><br>amiloride therapy. To examine this, three 24 hour urine samples are collected.<br /><br>The first is collected at the beginning of the study, the second after first<br /><br>six weeks of treatment and the last after the final six weeks of treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Assessment of quality of life (SF-36)<br /><br>Frequency of sleep distrubance (ISI)<br /><br>Assessment of the prevalence of diabetes insipidus in patients on lithium<br /><br>therapy<br /><br><br /><br>Other study parameters include changes in renal function or mean serum lithium<br /><br>concentration.<br /><br>Change in urinary concentrating after study medication<br /><br>Additionally changes in plasma renin and co-peptin will be assessed as measures<br /><br>of extracellular volume status and ADH activity.<br /><br>Change in aquaporin clearance by urinary exosome excretion.</p><br>