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
Recruitment status was Recruiting
Sponsor:
Hillel Yaffe Medical Center
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 12, 2010 | ||||
| Last Updated Date | April 27, 2010 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01112150 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Normatec Pump for Relief of Leg Edema | ||||
| Official Title ICMJE | Effect of Normatec Pump for Relief of Leg Edema: Short- Intermediate- and Longer-term Outcomes | ||||
| 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Device: NormaTec Pump
Normatec Pump |
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | July 2012 | ||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 19 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01112150 | ||||
| Other Study ID Numbers ICMJE | 0063-09-HYMC-CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | David S. Blondheim, Hillel Yaffe Medical Center | ||||
| Study Sponsor ICMJE | Hillel Yaffe Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Hillel Yaffe Medical Center | ||||
| Verification Date | April 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||