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Clinical Trials/NCT05307042
NCT05307042
Unknown
Not Applicable

Decline in Renal Concentration Ability in Lithium Treated Patients

Radboud University Medical Center1 site in 1 country51 target enrollmentMay 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lithium Toxicities
Sponsor
Radboud University Medical Center
Enrollment
51
Locations
1
Primary Endpoint
Decline renal concentration ability
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2022
End Date
December 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary 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.

Secondary Outcomes

  • Chronic kidney disease(10 years)
  • Relation between changes in kidney function and renal concentration ability(10 years)
  • Decline in kidney-function(10 years)
  • Relation between history of lithium-use and renal concentration ability(10 years)

Study Sites (1)

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