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Completed

NCT Number: NCT00507650

Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluid intervention

Dietary Supplement

Volume of fluid prescribed by physician or provider/day X 5 days.

Fluid intervention plus 10 ml/kg/day

Dietary Supplement

Fluid volume and type prescribed by physician or provider plus 10 ml/kg/day X 5 days.

Primary outcomes

  1. Collagen deposition

    Time frame: 10 days

Secondary outcomes

  1. Total body water

    Time frame: 10 days

  2. Safety - development of heart failure

    Time frame: Study duration

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Supplement Fluid & Collagen Deposition

Important dates

Study start
2003
Study completion
2007
First posted
Jul 26, 2007
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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