Effect of Normatec Pump for Relief of Leg Edema: Short- Intermediate- and Longer-term Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Weight Loss
研究概览
简要总结
The investigators hypothesize that leg edema will decrease rapidly when using the NormaTec pump, patients will lose weight, will feel better, will be less prone to infections in their legs and to congestion of the liver. Temporary elevation of intravascular fluid volume by the mobilized edema fluid returned to the intravascular space by pumping may increase cardiac output and renal perfusion and in addition it may distend the right atrium and ventricle thus inducing BNP secretion. Both mechanisms may promote excess fluid removal by the kidneys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemodynamically stable adult patients with pronounced leg edema from any etiology, on optimal medical therapy (such as diuretics, ACE-I or ARBs, digoxin).
- •documentation of right heart failure by Echo or other modality (CT, MRI, right heart catheterization) and hemodynamic data from Echo is required and an elevated pulmonary artery pressure (> 35 mmHg) is expected in such cases.
排除标准
- •patients in sepsis,
- •hemodynamically unstable,
- •during an acute attack of pulmonary edema,
- •with renal failure (creatinine > 2 mg%),
- •with DVT,
- •psychiatric or noncompliant patients, and
- •patients who will not sign the informed consent form will be excluded from the study.
研究组 & 干预措施
Pumping group
Patients in this arm will get a pumping session 2-3 times a day .
干预措施: NormaTec Pump (Device)
No pumping
These patients will not receive pumping but only classical treatment clinically indicated (diuretics, oxygen, Digoxin, Nitrates, ACE inhibitors etc, as necessary)
干预措施: NormaTec Pump (Device)
结局指标
主要结局
Weight Loss
时间窗: 5 days
The weight loss during the pumping pariod is related to fluid loss from edematous legs.
次要结局
- Leg circumference(5 Days)