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

Hyponatremia Clinical Trial

— NATRIPHAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212211
• Other study ID #: 2010-A00778-31
• Status: Completed
• Phase: N/A
• First received: September 10, 2010
• Last updated: May 22, 2012
• Start date: December 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyponatremia

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Carentan	Carentan

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No