Clinical trial NCT05307042: Decline in Renal Concentration Ability in Lithium Treated Patients
Official title: Decline in Renal Concentration Ability in Lithium Treated Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lithium Toxicities
Bipolar Disorder
Concentration Ability Impaired
Nephrogenic Diabetes Insipidus
Lithium - Induced Nephropathy
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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
  * 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

Primary outcomes:
measure: Decline renal concentration ability
timeFrame: 10 years
Secondary outcomes:
measure: Relation between changes in kidney function and renal concentration ability
timeFrame: 10 years
measure: Relation between history of lithium-use and renal concentration ability
timeFrame: 10 years
measure: Chronic kidney disease
timeFrame: 10 years
measure: Decline in kidney-function
timeFrame: 10 years
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: T. Nijenhuis
role: PRINCIPAL_INVESTIGATOR
References: