Analysis of Factors Determining Increase of Serum Sodium in Hyponatremic Patients

Hyponatremia Clinical Trial

Official title:

Prediction of Timely Evolution of Plasma Sodium in Treatment of Hyponatremia - Post Hoc-analysis of the Hyponatremia Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05277584
• Other study ID #: 01
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2023
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

1. Is the baseline sodium level a predominant factor determining the rapidity of sodium increase?

2. Ist he rapidity of sodium increase correlated to the given treatment?

3. Can other predominant factors of slope of sodium increase be determined?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3460
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients, who could not be assigned to one etiology group

Related Conditions & MeSH terms

• Hyponatremia

Locations

Country	Name	City	State
Germany	Department II of Internal Medicine,University of Cologne	Cologne

Sponsors (2)

Lead Sponsor	Collaborator
University of Cologne	Department of Mathematics and Computer Science, University of Technology Eindhoven

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Enrollment