Lithium ToxicitiesNCT05307042
Decline in Renal Concentration Ability in Lithium Treated Patients
An observational study of Lithium Toxicities and Bipolar Disorder, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lithium Toxicities, Bipolar Disorder, Concentration Ability Impaired
- What is being tested?
- Deamino Arginine Vasopressin (dDAVP)
- How many people
- 51 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2022to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- included in the previous study
- men and women
- age ≥ 18 years
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6532SZ
E.M. Bisseling, e.bisseling@cwz.nl
About this study
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.
- Conditions
- Lithium Toxicities, Bipolar Disorder, Concentration Ability Impaired, Nephrogenic Diabetes Insipidus, Lithium - Induced Nephropathy
- Being tested
- Deamino Arginine Vasopressin (dDAVP)
- Medical subject headings
- Bipolar Disorder, Diabetes Insipidus, Nephrogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deamino Arginine Vasopressin (dDAVP)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 2012-cohort | Not described Receives: Diagnostic Test: Deamino Arginine Vasopressin (dDAVP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline renal concentration ability
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.
Measured: 10 years
Secondary outcomes (4)
Relation between changes in kidney function and renal concentration ability
To determine the correlation between changes in kidney function and renal concentration ability
Measured: 10 years
Relation between history of lithium-use and renal concentration ability
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.
Measured: 10 years
Chronic kidney disease
To determine the number of patients with chronic kidney disease at follow-up.
Measured: 10 years
Decline in kidney-function
To explore the decline in kidneyfunction (expressed as eGFR, estimated by the CKD-EPI equation).
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study startMay 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lithium ToxicitiesStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- T. Nijenhuis, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307042
- Sponsor's protocol ID
- NL72701.091.20
- Status last verified
- Mar 2022
- First submitted
- 23 Mar 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decline in Renal Concentration Ability in Lithium Treated Patients
- ClinicalTrials.gov ID
- NCT05307042
- Acronym / sponsor ID
- NL72701.091.20
- Conditions
- Lithium Toxicities, Bipolar Disorder, Concentration Ability Impaired, Nephrogenic Diabetes Insipidus, Lithium - Induced Nephropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2012-cohort | – | Diagnostic Test: Deamino Arginine Vasopressin (dDAVP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- included in the previous study
- men and women
- age ≥ 18 years
Key exclusion criteria (19 listed)
- General contra-indications for participation in a trial:
- Alternative causes of (nephrogenic) diabetes insipidus:
- Contra-indications for dDAVP administration:
- Other:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | 2012-cohort |
Primary outcome
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.
4 secondary outcomes
Relation between changes in kidney function and renal concentration ability
Time frame: 10 years
Relation between history of lithium-use and renal concentration ability
Time frame: 10 years
Chronic kidney disease
Time frame: 10 years
Decline in kidney-function
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
T. Nijenhuis principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lithium Toxicities and Bipolar Disorder, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M.J. van der Aa ((073) 553 30 71, merel.vanderaa@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decline renal concentration ability (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.