NCT05277584

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

March 3, 2022

Last Update Submit

May 17, 2023

Conditions

Hyponatremia

Keywords

Hyponatremia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients with hyponatremia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department II of Internal Medicine,University of Cologne

Cologne, 50937, Germany

Location

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Volker Burst, MD

    Department II of Internal Medicine, University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. MD

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 14, 2022

Study Start

December 1, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

May 19, 2023

Record last verified: 2023-05

Locations

DE(1)