Effect of Normatec Pump for Relief of Leg Edema - Full Text View

Sponsor:	Hillel Yaffe Medical Center
Information provided by:	Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:	NCT01112150

Purpose

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.

Condition	Intervention
Edema Heart Failure Pulmonary Hypertension	Device: NormaTec Pump

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Effect of Normatec Pump for Relief of Leg Edema: Short- Intermediate- and Longer-term Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Edema Heart Failure High Blood Pressure Pulmonary Hypertension Weight Control

U.S. FDA Resources

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:

Weight Loss [ Time Frame: 5 days ] [ Designated as safety issue: No ]
The weight loss during the pumping pariod is related to fluid loss from edematous legs.

Secondary Outcome Measures:

Leg circumference [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
The leg circumference will be measured before and after each pumping session to determine the effectiveness of the pumping.

Estimated Enrollment:	20
Study Start Date:	April 2010
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Pumping group Patients in this arm will get a pumping session 2-3 times a day .	Device: NormaTec Pump Normatec Pump
Active Comparator: No pumping These patients will not receive pumping but only classical treatment clinically indicated (diuretics, oxygen, Digoxin, Nitrates, ACE inhibitors etc, as necessary)	Device: NormaTec Pump Normatec Pump

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112150

Contacts

Contact: David S. Blondheim, MD

97246304488

Locations

Israel
Hille Yaffe Medical Ceter	Recruiting
Hadera, Israel, 38100
Contact: David S Blondheim, MD 97246304488
Principal Investigator: David S. Blondheim, MD

Sponsors and Collaborators

Hillel Yaffe Medical Center

More Information

No publications provided

Responsible Party:	David S. Blondheim, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:	NCT01112150 History of Changes
Other Study ID Numbers:	0063-09-HYMC-CTIL
Study First Received:	April 12, 2010
Last Updated:	April 27, 2010
Health Authority:	Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:

Edema
Heart failure
Pulmonary hypertension
Edema in legs

Additional relevant MeSH terms:

Edema
Heart Failure
Hypertension
Hypertension, Pulmonary
Signs and Symptoms

Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2012