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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05307042
Other study ID # NL72701.091.20
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2022
Est. completion date December 2022

Study information

Verified date March 2022
Source Radboud University Medical Center
Contact M.J. van der Aa
Phone (073) 553 30 71
Email merel.vanderaa@radboudumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 51
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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 Design


Intervention

Diagnostic Test:
Deamino Arginine Vasopressin (dDAVP)
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.

Locations

Country Name City State
Netherlands Canisius Wilhelmina Ziekenhuis Nijmegen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Relation between history of lithium-use and renal concentration ability 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
Secondary Chronic kidney disease To determine the number of patients with chronic kidney disease at follow-up. 10 years
Secondary Decline in kidney-function To explore the decline in kidneyfunction (expressed as eGFR, estimated by the CKD-EPI equation). 10 years
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