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

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).

Study Overview

• Status: Completed
• Conditions: Hyponatremia
• Intervention / Treatment: Other: change in drug therapy

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Carentan, France, 50500
    • Centre Hospitalier Carentan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
No Intervention: reference; drug treatment of ten patients will remain unchanged during the three months of inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the benefit of a change of drug therapy following a review pharmacologist on the increase in serum sodium in elderly	Normalization serum sodium between S0 and S4 (4 weeks after medical intervention)	Fourth week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normalization of serum sodium-Evaluate the impact on the deficit postural S4-Evaluate the impact on the occurrence of falls	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	three months

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Blandine De la Gastine, MD, University Hospital, Caen

Publications and helpful links

General Publications

• Peyro Saint Paul L, Martin J, Gaillard C, Mosquet B, Coquerel A, de la Gastine B. [Moderate potentially drug-induced hyponatremia in older adults: benefit in drug reduction]. Therapie. 2013 Nov-Dec;68(6):341-6. doi: 10.2515/therapie/2013058. Epub 2013 Nov 11. French.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: September 10, 2010
• First Submitted That Met QC Criteria: September 29, 2010
• First Posted (Estimated): September 30, 2010

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Gait; elderly; Falls; Hyponatremia; Sodium level
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Nutritional and Metabolic Diseases; Hyponatremia; Therapeutics; Drug Therapy
• Other Study ID Numbers: 2010-A00778-31