Hyponatremia in the Elderly: Benefit From a Change in Drug Therapy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Evaluate the benefit of a change of drug therapy following a review pharmacologist on the increase in serum sodium in elderly
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Venous system does not allow sampling - Patient not taking medication-Dementia
研究组 & 干预措施
reference
drug treatment of ten patients will remain unchanged during the three months of inclusion
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
干预措施: change in drug therapy (Other)
结局指标
主要结局
Evaluate the benefit of a change of drug therapy following a review pharmacologist on the increase in serum sodium in elderly
时间窗: Fourth week
Normalization serum sodium between S0 and S4 (4 weeks after medical intervention)
次要结局
- Normalization of serum sodium-Evaluate the impact on the deficit postural S4-Evaluate the impact on the occurrence of falls(three months)
