Decline in Renal Concentration Ability in Lithium Treated Patients

NCT05307042 | Unknown

• 1 other identifier: NL72701.091.20
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lithium Toxicities; Bipolar Disorder; Concentration Ability Impaired; Nephrogenic Diabetes Insipidus; Lithium - Induced Nephropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Relation between changes in kidney function and renal concentration ability

  10 years

• Relation between history of lithium-use and renal concentration ability

  10 years

• Chronic kidney disease

  10 years

• Decline in kidney-function

  10 years

Study Arms (1)

2012-cohort

Diagnostic Test: Deamino Arginine Vasopressin (dDAVP)

Interventions

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.

2012-cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• included in the previous study
• men and women
• age ≥ 18 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Canisius Wilhelmina Ziekenhuis

Nijmegen, Gelderland, 6532SZ, Netherlands

Location

MeSH Terms

Conditions

Bipolar Disorder; Diabetes Insipidus, Nephrogenic

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Diabetes Insipidus; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• T. Nijenhuis

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M.J. van der Aa

CONTACT

(073) 553 30 71; merel.vanderaa@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

NL (1)