Effect of Normatec Pump for Relief of Leg Edema

Not Applicable

• Conditions: Edema; Heart Failure; Pulmonary Hypertension
• Interventions: Device: NormaTec Pump

• Registration Number: NCT01112150
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-04
• Study Start: 2010-04
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-27
• Last Update Submitted: 2010-04-27
• Study First Posted: 2010-04-28
• Last Update Posted: 2010-04-28
• Primary Completion: 2012-04
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pumping group	NormaTec Pump	Patients in this arm will get a pumping session 2-3 times a day .
No pumping	NormaTec Pump	These patients will not receive pumping but only classical treatment clinically indicated (diuretics, oxygen, Digoxin, Nitrates, ACE inhibitors etc, as necessary)

Primary Outcome Measures

Name	Time	Method
Weight Loss	5 days	The weight loss during the pumping pariod is related to fluid loss from edematous legs.

Secondary Outcome Measures

Name	Time	Method
Leg circumference	5 Days	The leg circumference will be measured before and after each pumping session to determine the effectiveness of the pumping.

Trial Locations

Locations (1)

Hille Yaffe Medical Ceter; 🇮🇱 Hadera, Israel