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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
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

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

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 24, 2007
    Last Updated
    March 5, 2015
    Sponsor
    University of California, San Francisco
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    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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