Effect of Normatec Pump for Relief of Leg Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01112150
Recruitment Status : Unknown
Verified April 2010 by Hillel Yaffe Medical Center.
Recruitment status was:  Recruiting
First Posted : April 28, 2010
Last Update Posted : April 28, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Edema Heart Failure Pulmonary Hypertension Device: NormaTec Pump Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Normatec Pump for Relief of Leg Edema: Short- Intermediate- and Longer-term Outcomes
Study Start Date : April 2010
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 5 days ]
    The weight loss during the pumping pariod is related to fluid loss from edematous legs.

Secondary Outcome Measures :
  1. Leg circumference [ Time Frame: 5 Days ]
    The leg circumference will be measured before and after each pumping session to determine the effectiveness of the pumping.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01112150

Contact: David S. Blondheim, MD 97246304488

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

Responsible Party: David S. Blondheim, Hillel Yaffe Medical Center Identifier: NCT01112150     History of Changes
Other Study ID Numbers: 0063-09-HYMC-CTIL
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: April 28, 2010
Last Verified: April 2010

Keywords provided by Hillel Yaffe Medical Center:
Heart failure
Pulmonary hypertension
Edema in legs

Additional relevant MeSH terms:
Heart Failure
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases