HyponatremiaNCT05277584
Analysis of Factors Determining Increase of Serum Sodium in Hyponatremic Patients
An observational study of Hyponatremia, run by University of Cologne at 1 site in Germany.
Trial summary
The aim of this study is to further analyse the dataset of the Hyponatremia Registry, a multicenter, prospective, observational study conducted between September 2020 and February 2013 in the United States of America and the European Union. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia
- How many people
- 3,460 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2021to 31 Mar 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: Patients with hypotonic hyponatremia <130 mmol/l enrolled in the Hyponatremia Registry (NH-Registry)
Who may be able to join
- Patients with hypotonic hyponatremia <130 mmol/l enrolled in the Hyponatremia Registry and classified as Euvolemic Hyponatremia, Hypervolemic Hyponatremia, Hypovolemic Hyponatremia or Thiazide associated Hyponatremia-Group
Who cannot join
- Patients, who could not be assigned to one etiology group
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department II of Internal Medicine,University of Cologne
Cologne, 50937
About this study
Official title: Prediction of Timely Evolution of Plasma Sodium in Treatment of Hyponatremia - Post Hoc-analysis of the Hyponatremia Registry
The aim of this study is to further analyse the dataset of the Hyponatremia Registry, a multicenter, prospective, observational study conducted between September 2020 and February 2013 in the United States of America and the European Union. The primary interest was to provide evidence to investigators' hypothesis that baseline sodium levels are a predominant factor determining the rapidity of sodium increase irrespective of the given treatment. Further investigators aimed to identify other independent predictors of the increase of plasma sodium upon treatment.
Read the detailed description
Hyponatremia is the most common electrolyte disorder in outpatients and hospitalized patients. Overly rapid sodium increase is associated with increased risk for osmotic demyelination. Smaller analyses have suggested that the slope of the sodium increment is higher with lower baseline sodium levels but this has not been confirmed in large datasets. Investigators have recently published the results of analysis on patients from the Otsuka HN-Registry on thiazide-induced hyponatremia (cooperation with Otsuka). In that dataset was founded the same association and there had been hints that this relationship holds true for all kinds of treatment including no treatment at all.
Investigators took the datasets of those patients presenting with Hyponatremia that could be classified into one etiology group by the treating physician for further analysis. Patients with euvolemic, hypervolemic, hypovolemic or thiazide-associated HN were included in investigators' analysis. Furthermore investigators only considered those cases in which the patient record provided at least one documented plasma [Na+] within <25 hours after the first plasma [Na+] ≤130mEq/L had been measured.
All variables collected in the HN registry were included in the data base. All available information on ingested or administered solutes was recorded. Linear mixed effects models were applied to conduct multivariable repeated measures analyses.
Following questions are to be answered in this study
- Is the baseline sodium level a predominant factor determining the rapidity of sodium increase?
- Ist he rapidity of sodium increase correlated to the given treatment?
- Can other predominant factors of slope of sodium increase be determined?
- Conditions
- Hyponatremia
- Keywords
- Hyponatremia
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hyponatremia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of [Na+] slope due to therapy
Assessing Evolution of plasma sodium within the first 24 hours after commencement of therapy to determine predictors for velocity of [Na+] increase.
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Dec 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,460 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Mathematics and Computer Science, University of Technology Eindhoven
- Responsible party
- Principal investigator, Volker Burst, University of Cologne
- Investigators
- Volker Burst, MD, Principal investigator, Department II of Internal Medicine, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277584
- Sponsor's protocol ID
- 01
- Status last verified
- May 2023
- First submitted
- 3 Mar 2022
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Timely Evolution of Plasma Sodium in Treatment of Hyponatremia - Post Hoc-analysis of the Hyponatremia Registry
- ClinicalTrials.gov ID
- NCT05277584
- Acronym / sponsor ID
- 01
- Conditions
- Hyponatremia
- Keywords
- Hyponatremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,460 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Department of Mathematics and Computer Science, University of Technology Eindhoven
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 14 Mar 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.
The aim of this study is to further analyse the dataset of the Hyponatremia Registry, a multicenter, prospective, observational study conducted between September 2020 and February 2013 in the United States of America and the European Union. The primary interest was to provide evidence to investigators' hypothesis that baseline sodium levels are a predominant factor determining the rapidity of sodium increase irrespective of the given treatment. Further investigators aimed to identify other independent predictors of the increase of plasma sodium upon treatment.
Detailed description
Hyponatremia is the most common electrolyte disorder in outpatients and hospitalized patients. Overly rapid sodium increase is associated with increased risk for osmotic demyelination. Smaller analyses have suggested that the slope of the sodium increment is higher with lower baseline sodium levels but this has not been confirmed in large datasets. Investigators have recently published the results of analysis on patients from the Otsuka HN-Registry on thiazide-induced hyponatremia (cooperation with Otsuka). In that dataset was founded the same association and there had been hints that this relationship holds true for all kinds of treatment including no treatment at all.
Investigators took the datasets of those patients presenting with Hyponatremia that could be classified into one etiology group by the treating physician for further analysis. Patients with euvolemic, hypervolemic, hypovolemic or thiazide-associated HN were included in investigators' analysis. Furthermore investigators only considered those cases in which the patient record provided at least one documented plasma [Na+] within <25 hours after the first plasma [Na+] ≤130mEq/L had been measured.
All variables collected in the HN registry were included in the data base. All available information on ingested or administered solutes was recorded. Linear mixed effects models were applied to conduct multivariable repeated measures analyses.
Following questions are to be answered in this study
- Is the baseline sodium level a predominant factor determining the rapidity of sodium increase?
- Ist he rapidity of sodium increase correlated to the given treatment?
- Can other predominant factors of slope of sodium increase be determined?
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hyponatremia | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hypotonic hyponatremia <130 mmol/l enrolled in the Hyponatremia Registry (NH-Registry)
Key inclusion criteria (1 listed)
- Patients with hypotonic hyponatremia <130 mmol/l enrolled in the Hyponatremia Registry and classified as Euvolemic Hyponatremia, Hypervolemic Hyponatremia, Hypovolemic Hyponatremia or Thiazide associated Hyponatremia-Group
Key exclusion criteria (1 listed)
- Patients, who could not be assigned to one etiology group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictors of [Na+] slope due to therapy
Time frame: Enrollment
Assessing Evolution of plasma sodium within the first 24 hours after commencement of therapy to determine predictors for velocity of [Na+] increase.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
Related trials for Hyponatremia
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Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
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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.
Volker Burst, MD principal investigator
Department II of Internal Medicine, University of Cologne
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 Hyponatremia, run by University of Cologne at 1 site in Germany.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 May 2023. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictors of [Na+] slope due to therapy (time frame: Enrollment). 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 19 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.