Effect of Normatec Pump for Relief of Leg Edema

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Normatec Pump for Relief of Leg Edema: Short- Intermediate- and Longer-term Outcomes

Conditions
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Edema, Heart Failure, Pulmonary Hypertension

Intervention / Treatment
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* Device: NormaTec Pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pumping group<br>Patients in this arm will get a pumping session 2-3 times a day . | Device: NormaTec Pump<br>* Normatec Pump<br>|
| Active Comparator: No pumping<br>These patients will not receive pumping but only classical treatment clinically indicated (diuretics, oxygen, Digoxin, Nitrates, ACE inhibitors etc, as necessary) | Device: NormaTec Pump<br>* Normatec Pump<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | The weight loss during the pumping pariod is related to fluid loss from edematous legs. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg circumference | The leg circumference will be measured before and after each pumping session to determine the effectiveness of the pumping. | 5 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Edema, Heart failure, Pulmonary hypertension, Edema in legs