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

Effect of amiloride on polyuria and well being in lithium treated patients - Polyuria in Lithium Treatment (PoLiTreat)

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46002
Enrollment
20
Registered
2017-04-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Insipidus. Frequent urination

Interventions

The intervention consists of 12 weeks of treatment, 6 weeks amiloride, 6 weeks placebo. Additionally, patients are instructed to undergo a water deprivation test three times, to fill out questionnai

Sponsors

Maasstadziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main endpoint is the change in 24 hour urine volume after intervention with amiloride therapy. To examine this, three 24 hour urine samples are collected. The first is collected at the beginning of the study, the second after first six weeks of treatment and the last after the final six weeks of treatment.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)