Decline in Renal Concentration Ability in Lithium Treated Patients

• Conditions: Concentration Ability Impaired; Lithium Toxicities; Bipolar Disorder; Lithium - Induced Nephropathy; Nephrogenic Diabetes Insipidus
• Interventions: Diagnostic Test: Deamino Arginine Vasopressin (dDAVP)

• Registration Number: NCT05307042
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-03-23
• Last Update Submitted: 2022-03-23
• Study First Posted: 2022-04-01
• Last Update Posted: 2022-04-01
• Study Start: 2022-05
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2012-cohort	Deamino Arginine Vasopressin (dDAVP)	-

Primary Outcome Measures

Name	Time	Method
Decline renal concentration ability	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 Outcome Measures

Name	Time	Method
Chronic kidney disease	10 years	To determine the number of patients with chronic kidney disease at follow-up.
Relation between changes in kidney function and renal concentration ability	10 years	To determine the correlation between changes in kidney function and renal concentration ability
Decline in kidney-function	10 years	To explore the decline in kidneyfunction (expressed as eGFR, estimated by the CKD-EPI equation).
Relation between history of lithium-use and renal concentration ability	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.

Trial Locations

Locations (1)

Canisius Wilhelmina Ziekenhuis; 🇳🇱 Nijmegen, Gelderland, Netherlands