Back to resultsEffect of Normatec Pump for Relief of Leg Edema
Primary Purpose
Edema, Heart Failure, Pulmonary Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
NormaTec Pump
Sponsored by
About this trial
This is an interventional supportive care trial for Edema focused on measuring Edema, Heart failure, Pulmonary hypertension, Edema in legs
Eligibility 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.
Sites / Locations
- Hille Yaffe Medical CeterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pumping group
No pumping
Arm Description
Patients in this arm will get a pumping session 2-3 times a day .
These patients will not receive pumping but only classical treatment clinically indicated (diuretics, oxygen, Digoxin, Nitrates, ACE inhibitors etc, as necessary)
Outcomes
Primary Outcome Measures
Weight Loss
The weight loss during the pumping pariod is related to fluid loss from edematous legs.
Secondary Outcome Measures
Leg circumference
The leg circumference will be measured before and after each pumping session to determine the effectiveness of the pumping.
Full Information
NCT ID
NCT01112150
First Posted
April 12, 2010
Last Updated
April 27, 2010
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01112150
Brief Title
Effect of Normatec Pump for Relief of Leg Edema
Official Title
Effect of Normatec Pump for Relief of Leg Edema: Short- Intermediate- and Longer-term Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema, Heart Failure, Pulmonary Hypertension
Keywords
Edema, Heart failure, Pulmonary hypertension, Edema in legs
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pumping group
Arm Type
Active Comparator
Arm Description
Patients in this arm will get a pumping session 2-3 times a day .
Arm Title
No pumping
Arm Type
Active Comparator
Arm Description
These patients will not receive pumping but only classical treatment clinically indicated (diuretics, oxygen, Digoxin, Nitrates, ACE inhibitors etc, as necessary)
Intervention Type
Device
Intervention Name(s)
NormaTec Pump
Intervention Description
Normatec Pump
Primary Outcome Measure Information:
Title
Weight Loss
Description
The weight loss during the pumping pariod is related to fluid loss from edematous legs.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Leg circumference
Description
The leg circumference will be measured before and after each pumping session to determine the effectiveness of the pumping.
Time Frame
5 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David S. Blondheim, MD
Phone
97246304488
Facility Information:
Facility Name
Hille Yaffe Medical Ceter
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David S Blondheim, MD
Phone
97246304488
First Name & Middle Initial & Last Name & Degree
David S. Blondheim, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of Normatec Pump for Relief of Leg Edema
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