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

NCT01212211 | Completed

• 1 other identifier: 2010-A00778-31
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Hyponatremia

Keywords

Hyponatremia; Sodium level; Falls; Gait; elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  three months

Study Arms (2)

change in drug therapy

EXPERIMENTAL

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

reference

NO INTERVENTION

drug treatment of ten patients will remain unchanged during the three months of inclusion

Interventions

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

change in drug therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Centre Hospitalier Carentan

Carentan, 50500, France

Location

Related Publications (1)

• 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.

  PMID: 24246119 RESULT

MeSH Terms

Conditions

Hyponatremia

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Blandine De la Gastine, MD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 30, 2010
• Study Start: December 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: May 1, 2012
• Last Updated: April 2, 2026

Record last verified: 2012-05

Locations

FR (1)