Decline in Renal Concentration Ability in Lithium Treated Patients
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Decline renal concentration ability
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •concomitant treatment with desmopressin or democlocycline
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)