Decline in Renal Concentration Ability in Lithium Treated Patients

Bipolar Disorder Clinical Trial

Official title:

Decline in Renal Concentration Ability in Lithium Treated Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05307042
• Other study ID #: NL72701.091.20
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Bipolar Disorder
• Concentration Ability Impaired
• Diabetes Insipidus
• Diabetes Insipidus, Nephrogenic
• Nephrogenic Diabetes Insipidus

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