Skip to main content
OpenTrials
Completed

NCT Number: NCT01212211

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Carentan

Carentan, 50500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient over 65 years Resident of dependent elderly
  • Plasma sodium <135 mmol / l less than a week, confirming earlier hyponatremia within a week to three month agreement given after patient information

Exclusion criteria

  • Venous system does not allow sampling - Patient not taking medication-Dementia

Treatment and study plan

change in drug therapy

Other

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

Primary outcomes

  1. Evaluate the benefit of a change of drug therapy following a review pharmacologist on the increase in serum sodium in elderly

    Time frame: Fourth week

    Normalization serum sodium between S0 and S4 (4 weeks after medical intervention)

Secondary outcomes

  1. Normalization of serum sodium-Evaluate the impact on the deficit postural S4-Evaluate the impact on the occurrence of falls

    Time frame: three months

    Changes in serum sodium weekly S1, S2, S3 - Evolution of the score evaluation of postural control: the Timed Up and Go test (TUG) between therapeutic intervention and S4-comparison of the number of falls between the period three months before and three months after surgery Medical Decision to three months whether to maintain the drug therapy changed

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: NATRIPHAR

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 30, 2010
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.