Effect of Normatec Pump for Relief of Leg Edema

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Hillel Yaffe Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01112150
First received: April 12, 2010
Last updated: April 27, 2010
Last verified: April 2010

April 12, 2010
April 27, 2010
April 2010
April 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01112150 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effect of Normatec Pump for Relief of Leg Edema
Effect of Normatec Pump for Relief of Leg Edema: Short- Intermediate- and Longer-term Outcomes

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Edema
  • Heart Failure
  • Pulmonary Hypertension
Device: NormaTec Pump
Normatec Pump
  • Active Comparator: Pumping group
    Patients in this arm will get a pumping session 2-3 times a day .
    Intervention: Device: 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)
    Intervention: Device: NormaTec Pump
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
July 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact: David S. Blondheim, MD 97246304488
Israel
 
NCT01112150
0063-09-HYMC-CTIL
No
David S. Blondheim, Hillel Yaffe Medical Center
Hillel Yaffe Medical Center
Not Provided
Not Provided
Hillel Yaffe Medical Center
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP