Effect of Normatec Pump for Relief of Leg Edema

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Edema; Heart Failure; Pulmonary Hypertension

Treatments: Device: NormaTec Pump

Study type: Interventional

Funder types: Other

Identifiers

NCT01112150

0063-09-HYMC-CTIL

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Pumping group

Active Comparator group

Description:

Patients in this arm will get a pumping session 2-3 times a day .

Treatment:

Device: NormaTec Pump

No pumping

Active Comparator group

Description:

These patients will not receive pumping but only classical treatment clinically indicated (diuretics, oxygen, Digoxin, Nitrates, ACE inhibitors etc, as necessary)

Treatment:

Device: NormaTec Pump