Decline in Renal Concentration Ability in Lithium Treated Patients

March 23, 2022 updated by: Radboud University Medical Center
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6532SZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2012-cohort
Diagnostic test: Deamino Arginine Vasopressin (dDAVP)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: T. Nijenhuis, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL72701.091.20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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