Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia

Summary

Hyponatremia is the most common electrolyte disorder with a prevalence of up to 30% in hospitalized patients. While treatment of acute hyponatremia with severe clinical symptoms due to cerebral edema is undisputed and straightforward, hyponatremia in general is usually considered asymptomatic or not clinically relevant. Accordingly, a recent observational study showed that appropriate laboratory tests to evaluate the etiology of hyponatremia were obtained in less than 50% of patients, leading to 75% of patients being still hyponatremic at discharge.

This is problematic in the context of increasing evidence, revealing an association of chronic hyponatremia with adverse effects such as gait alterations and falls, attention deficits, bone loss and fractures as well as disease-associated morbidity leading to increased rates of readmissions and mortality. Yet, there is a complete lack of randomized clinical trials with the primary aim to investigate whether correction of plasma sodium concentration counteracts the elevated risk of rehospitalization and mortality.

The aim of this trial is therefore to determine the effects on mortality and rehospitalization rate of a targeted correction of plasma sodium concentration in addition to current standard care in hospitalized hyponatremic patients.

Conditions

• Hyponatremia

Interventions

OTHER

Targeted correction of plasma sodium levels

Targeted correction of hyponatremia

OTHER

Standard care

Standard care of hyponatremia

Sponsors & Collaborators

• Erasmus Medical Center

  collaborator OTHER

• Cantonal Hospital of Aarau, Switzerland

  collaborator OTHER

• Spital Solothurn, Switzerland

  collaborator UNKNOWN

• Kantonsspital St. Gallen, Switzerland

  collaborator UNKNOWN

• Kantonsspital Liestal, Switzerland

  collaborator UNKNOWN

• Universitätsklinikum Köln

  collaborator OTHER

• KBC Zagreb, Croatia

  collaborator UNKNOWN

• Azienda Ospedaliero-Universitaria Careggi

  collaborator OTHER

• University Hospital, Basel, Switzerland

  lead OTHER

Principal Investigators

• Mirjam Christ-Crain, Prof. MD · University Hospital, Basel, Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-20

Primary Completion

2025-04-30

Completion

2025-04-30

Countries

• Croatia
• Germany
• Italy
• Netherlands
• Switzerland

Study Locations