Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers
Primary Purpose
Pressure Ulcers
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluid intervention
Fluid intervention plus 10 ml/kg/day
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcers focused on measuring Pressure ulcers, Geriatrics, Nursing home, Fluid balance, Collagen deposition
Eligibility Criteria
Inclusion Criteria:
- Persons age =/> 60 years at risk for pressure ulcers (Braden Scale score <18 or nonblanchable erythema [Stage 1 ulcer]) or with a Stage II-IV pressure ulcer and WBC of at least 2,000/mm3
Exclusion Criteria:
Those:
- Who have or have had heart failure or renal failure/insufficiency
- Who currently smoke
- With acute illness or having experienced it in the last 7 days
- Taking immunosuppressive drugs
- With an implantable defibrillator
- With a glycosylated hemoglobin of >8%
- With a body mass index is <21 kg/m2 or > 30 kg/m2; and
- Being treated for dehydration.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Prescribed
Supplemental
Arm Description
Fluid volume and type prescribed by MD or provider.
Fluid volume and type prescribed by physician or provider plus 10 ml/kg X 5 days.
Outcomes
Primary Outcome Measures
Collagen deposition
Secondary Outcome Measures
Total body water
Safety - development of heart failure
Full Information
NCT ID
NCT00507650
First Posted
July 24, 2007
Last Updated
March 5, 2015
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00507650
Brief Title
Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers
Official Title
Supplement Fluid & Collagen Deposition
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether providing extra fluid to nursing home residents will help prevent or heal pressure ulcers. We hypothesize that providing extra fluid to nursing home residents will increase their skin blood flow and oxygen to support healing and maintaining healthy skin. Participants are enrolled who have a pressure ulcer or who are at-risk for an ulcer (determined by looking at risk factors). The study is divided into two 10 day phases. In Phase 1, we examine participant's usual status, including fluid intake and baseline healing potential. In Phase 2, participants are randomly placed in groups to receive either their usually prescribed fluid intake or additional fluid. A study nurse provides the fluid to the residents. We measure their actual intake, their body water, how well their kidneys are working, their potential to heal, and also monitor them for the development of fluid overload. This study is important because it helps us understand the role of a basic nursing intervention in the prevention and treatment of pressure ulcers.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
Keywords
Pressure ulcers, Geriatrics, Nursing home, Fluid balance, Collagen deposition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prescribed
Arm Type
Active Comparator
Arm Description
Fluid volume and type prescribed by MD or provider.
Arm Title
Supplemental
Arm Type
Experimental
Arm Description
Fluid volume and type prescribed by physician or provider plus 10 ml/kg X 5 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fluid intervention
Intervention Description
Volume of fluid prescribed by physician or provider/day X 5 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fluid intervention plus 10 ml/kg/day
Intervention Description
Fluid volume and type prescribed by physician or provider plus 10 ml/kg/day X 5 days.
Primary Outcome Measure Information:
Title
Collagen deposition
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Total body water
Time Frame
10 days
Title
Safety - development of heart failure
Time Frame
Study duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persons age =/> 60 years at risk for pressure ulcers (Braden Scale score <18 or nonblanchable erythema [Stage 1 ulcer]) or with a Stage II-IV pressure ulcer and WBC of at least 2,000/mm3
Exclusion Criteria:
Those:
Who have or have had heart failure or renal failure/insufficiency
Who currently smoke
With acute illness or having experienced it in the last 7 days
Taking immunosuppressive drugs
With an implantable defibrillator
With a glycosylated hemoglobin of >8%
With a body mass index is <21 kg/m2 or > 30 kg/m2; and
Being treated for dehydration.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy A. Stotts, RN, EdD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers
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