Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers
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|ClinicalTrials.gov Identifier: NCT00507650|
Recruitment Status : Completed
First Posted : July 26, 2007
Last Update Posted : March 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcers||Dietary Supplement: Fluid intervention Dietary Supplement: Fluid intervention plus 10 ml/kg/day||Not Applicable|
Pressure ulcers are prevalent in nursing homes. They heal slowly, cause pain, impair quality of life, and are expensive to treat. Dehydration is a problem in some nursing home residents and under-perfusion a problem in others. Theoretically, providing supplemental fluid to under-hydrated residents should increase fluid in the various fluid compartments of the body, increase subcutaneous oxygen, support skin integrity, enhance pressure ulcer blood flow and pressure ulcer healing, including collagen production. This proposition has not been examined in nursing home residents with pressure ulcers.
The purpose of this randomized clinical trial (RCT) in which subjects serve as their own control is to determine whether administration of supplemental fluid to nursing home residents with or at risk for pressure ulcers enhances collagen deposition. Specifically, this study will determine whether oral administration of supplemental fluid given daily for five days to persons with or at risk for pressure ulcers enhances collagen deposition, increases total body water, augments subcutaneous tissue oxygen, increases pressure ulcer oxygenation, and is safe.
The sample will be nursing home residents at risk for or with pressure ulcers. After consent, baseline measures of collagen deposition, pressure ulcer oxygen, fluid intake, and body water in the various fluid compartments are measured. Expanded polytetrafluoroethylene (ePTFE) tubes are used to measure collagen deposition. Bioelectrical impedance is used to measure body water. In the treatment phase, subjects are randomized to one of the two supplemental fluid regimes. Supplemental fluid is administered for five days and collagen deposition, subcutaneous tissue oxygen, pressure ulcer oxygen, and body water in the various compartments again measured. Subjects are monitored for fluid overload. Data are analyzed with RMANOVA and logistic regression techniques.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Supplement Fluid & Collagen Deposition|
|Study Start Date :||September 2003|
|Actual Study Completion Date :||March 2007|
Active Comparator: Prescribed
Fluid volume and type prescribed by MD or provider.
Dietary Supplement: Fluid intervention
Volume of fluid prescribed by physician or provider/day X 5 days.
Fluid volume and type prescribed by physician or provider plus 10 ml/kg X 5 days.
Dietary Supplement: Fluid intervention plus 10 ml/kg/day
Fluid volume and type prescribed by physician or provider plus 10 ml/kg/day X 5 days.
- Collagen deposition [ Time Frame: 10 days ]
- Total body water [ Time Frame: 10 days ]
- Safety - development of heart failure [ Time Frame: Study duration ]
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 ClinicalTrials.gov identifier (NCT number): NCT00507650
|Principal Investigator:||Nancy A. Stotts, RN, EdD||University of California, San Francisco|