Analysis of Factors Determining Increase of Serum Sodium in Hyponatremic Patients

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.

Study Overview

• Status: Completed
• Conditions: Hyponatremia

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

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?

• Study Type: Observational
• Enrollment (Actual): 3460

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50937
    • Department II of Internal Medicine,University of Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with hypotonic hyponatremia <130 mmol/l enrolled in the Hyponatremia Registry (NH-Registry)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with hyponatremia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Cologne
• Collaborators: Department of Mathematics and Computer Science, University of Technology Eindhoven
• Investigators: Principal Investigator: Volker Burst, MD, Department II of Internal Medicine, University of Cologne

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Hyponatremia
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia
• Other Study ID Numbers: 01 (Miami VAHS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No