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Effect of Normatec Pump for Relief of Leg Edema

NCT ID: NCT01112150

Last Updated: 2010-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-07-31

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.

Detailed Description

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Conditions

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Edema Heart Failure Pulmonary Hypertension

Keywords

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Edema Heart failure Pulmonary hypertension Edema in legs

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pumping group

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

Group Type ACTIVE_COMPARATOR

NormaTec Pump

Intervention Type DEVICE

Normatec Pump

No pumping

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

Group Type ACTIVE_COMPARATOR

NormaTec Pump

Intervention Type DEVICE

Normatec Pump

Interventions

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NormaTec Pump

Normatec Pump

Intervention Type DEVICE

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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hillel Yaffe Medical Center

Locations

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Hille Yaffe Medical Ceter

Hadera, Israel, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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David S. Blondheim, MD

Role: CONTACT

Phone: 97246304488

Facility Contacts

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David S Blondheim, MD

Role: primary

Other Identifiers

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0063-09-HYMC-CTIL

Identifier Type: -

Identifier Source: org_study_id