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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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).


Detailed Summary:
Sponsor: University Hospital, Caen

Current Primary Outcome: 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)


Original Primary Outcome: 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 ]

Increase of at least 4 points in serum sodium between S0 and S4 (4 weeks after medical intervention)


Current Secondary Outcome: 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


Original Secondary Outcome: Set time of 4 percentage points increase in 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


Information By: University Hospital, Caen

Dates:
Date Received: September 10, 2010
Date Started: December 2010
Date Completion:
Last Updated: May 22, 2012
Last Verified: May 2012