Hyponatremia in the Elderly: Benefit From a Change in Drug Therapy? (NATRIPHAR)
Primary Purpose
Hyponatremia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
change in drug therapy
Sponsored by
About this trial
This is an interventional prevention trial for Hyponatremia focused on measuring Hyponatremia; Sodium level, Falls, Gait, elderly
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
Sites / Locations
- Centre Hospitalier Carentan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
change in drug therapy
reference
Arm Description
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
drug treatment of ten patients will remain unchanged during the three months of inclusion
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01212211
First Posted
September 10, 2010
Last Updated
May 22, 2012
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT01212211
Brief Title
Hyponatremia in the Elderly: Benefit From a Change in Drug Therapy?
Acronym
NATRIPHAR
Official Title
Hyponatremia in the Elderly: Benefit From a Change in Drug Therapy?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia
Keywords
Hyponatremia; Sodium level, Falls, Gait, elderly
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
change in drug therapy
Arm Type
Experimental
Arm Description
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
Arm Title
reference
Arm Type
No Intervention
Arm Description
drug treatment of ten patients will remain unchanged during the three months of inclusion
Intervention Type
Other
Intervention Name(s)
change in drug therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluate the benefit of a change of drug therapy following a review pharmacologist on the increase in serum sodium in elderly
Description
Normalization serum sodium between S0 and S4 (4 weeks after medical intervention)
Time Frame
Fourth week
Secondary Outcome Measure Information:
Title
Normalization of serum sodium-Evaluate the impact on the deficit postural S4-Evaluate the impact on the occurrence of falls
Description
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
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blandine De la Gastine, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Carentan
City
Carentan
ZIP/Postal Code
50500
Country
France
12. IPD Sharing Statement
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Hyponatremia in the Elderly: Benefit From a Change in Drug Therapy?
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