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

NCT ID: NCT01212211

Last Updated: 2012-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

change in drug therapy

Intervention Type: 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

reference

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Blandine De la Gastine, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

Centre Hospitalier Carentan

Carentan, , France

Countries

France

Other Identifiers

2010-A00778-31

Identifier Type: -

Identifier Source: org_study_id