Status
Unknown
Phase
Not applicable
Enrollment
51
Locations
1
Results
Not posted
Publications
0
Study summary
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.
Interventions
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.
Timeline
First posted
Apr 1, 2022
Study start
May 2022
Primary completion
Dec 2022
Study completion
Dec 2022
Results posted
Not reported
Registry updated
Apr 1, 2022
Outcomes
Decline renal concentration ability
Time frame · 10 years
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.
Relation between changes in kidney function and renal concentration ability
Time frame · 10 years
To determine the correlation between changes in kidney function and renal concentration ability
Relation between history of lithium-use and renal concentration ability
Time frame · 10 years
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.
Chronic kidney disease
Time frame · 10 years
To determine the number of patients with chronic kidney disease at follow-up.
Decline in kidney-function
Time frame · 10 years
To explore the decline in kidneyfunction (expressed as eGFR, estimated by the CKD-EPI equation).
Eligibility
Inclusion Criteria: * included in the previous study * 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: * hypokalemia (plasma potassium \< 3.0 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 locations
Netherlands. Showing up to 24 locations stored in the fast local snapshot.
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands
Publications
No PMID-linked publications were present in this registry snapshot.
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