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Lithium therapy is cornerstone in therapy of bipolar disorders. A well known side-effect of lithium therapy is a urinary concentration defect which manifests in it's most severe form as nephrogenic diabetes insipidus. The development of urinary concentration defects and its progression to nephrogenic diabetes insipidus in the population of lithium treated patients is unknown and therefore this study aims to evaluate the decline of urinary concentration defects in a Dutch population of lithium treated patients. In this prospective cohort study, 51 participants treated with lithium at Canisius Wilhelmina Hospital, Nijmegen and included in the previous study in 2012 will be approached to undergo a follow-up dDAVP-test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2012-cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deamino Arginine Vasopressin (dDAVP) | Diagnostic Test | After voiding, 40 μg 1-desamino-8-D arginine vasopressin (dDAVP) will be administered intranasally. Throughout the day, urine volume and maximal renal concentrating ability will be determined by measuring osmolality in urine collected at 4 and 6 hours after administration of dDAVP. In addition, water intake, body weight, blood pressure and heart rate will be determined at baseline and 6 hours after administration of dDAVP. |
| Measure | Description | Time Frame |
|---|---|---|
| Decline renal concentration ability | To explore the decline in renal concentration ability (RCA) in a Dutch population of lithium treated patient. The primary endpoint is the percentual change in maximal urine osmolality. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Relation between changes in kidney function and renal concentration ability | To determine the correlation between changes in kidney function and renal concentration ability | 10 years |
| Relation between history of lithium-use and renal concentration ability |
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Inclusion Criteria:
Exclusion Criteria:
General contra-indications for participation in a trial:
Alternative causes of (nephrogenic) diabetes insipidus:
Contra-indications for dDAVP administration:
Other:
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The 51 patients treated with lithium who were included in the previous study in 2012/2013, in which they were subject to a dDAVP test.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| M.J. van der Aa | Contact | (073) 553 30 71 | merel.vanderaa@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| T. Nijenhuis | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canisius Wilhelmina Ziekenhuis | Nijmegen | Gelderland | 6532SZ | Netherlands |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D018500 | Diabetes Insipidus, Nephrogenic |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D003919 | Diabetes Insipidus |
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|
To determine the relationship between renal concentration ability 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. |
| 10 years |
| Chronic kidney disease | To determine the number of patients with chronic kidney disease at follow-up. | 10 years |
| Decline in kidney-function | To explore the decline in kidneyfunction (expressed as eGFR, estimated by the CKD-EPI equation). | 10 years |
| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |