MedTrace Logo

Hyponatremia in the Elderly: Benefit From a Change in Drug Therapy?

NCT01212211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-02

No results posted yet for this study

Summary

Mild hyponatremia is the commonest electrolyte imbalance in the older population. Recently, association between hyponatremia and bone fractures in the ambulatory elderly has been shown.

Mild chronic hyponatremia is causing falls and lead to hospitalisation because of attention deficit.

Symptoms related to hyponatremia can be very subtle and difficult to detect clinically. Twenty elderly patients, retirement homes residents, with serum sodium \< 135mEq/L will be included. They will be randomised. The physician will review the drug treatment of ten patients in coordination with the opinion of pharmacologists. Drug treatment for ten other patients wil remained unchanged during the three months of inclusion.

Useful elements of the medical records of patients randomized to the experimental arm will be forwarded to the Pharmacovigilance Regional Center for opinion pharmacologist. The notice, subject to the attention of physician of retirement homes, give rise to a therapeutic approach towards the patient. It will be followed by weekly monitoring of serum sodium for 4 weeks to evaluate the impact of the intervention. Thus, the effectiveness of medical intervention will be evaluated by an objective biological criteria: serum sodium in the fourth week. Secondary endpoints will evaluate the duration of normalization of serum sodium and check the interest of correcting hyponatremia to improve postural capacities and eventually reduce the number of falls in the medium term (three months).

Conditions

Interventions

OTHER

change in drug therapy

Change in drug therapy with the help of the opinion of pharmacologists : the physician would review the drug treatment of ten residents in coordination with the opinion of pharmacologists

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Blandine De la Gastine, MD · University Hospital, Caen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-01-31
Completion
2012-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01212211 on ClinicalTrials.gov