Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers

This study has been completed.
Information provided by:
University of California, San Francisco Identifier:
First received: July 24, 2007
Last updated: July 25, 2007
Last verified: July 2007

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.

Condition Intervention
Pressure Ulcers
Dietary Supplement: Fluid intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Supplement Fluid & Collagen Deposition

Resource links provided by NLM:

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Collagen deposition [ Time Frame: 10 days ]

Secondary Outcome Measures:
  • Total body water [ Time Frame: 10 days ]
  • Safety - development of heart failure [ Time Frame: Study duration ]

Enrollment: 63
Study Start Date: September 2003
Study Completion Date: March 2007
Arms Assigned Interventions
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.
Experimental: SUPPLEMENTAL
Fluid volume and type prescribed by physician or provider plus 10 ml/kg X 5 days.
Dietary Supplement: Fluid intervention
Fluid volume and type prescribed by physician or provider plus 10 ml/kg/day X 5 days.

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.


Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:


  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00507650

Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Nancy A. Stotts, RN, EdD University of California, San Francisco
  More Information

No publications provided Identifier: NCT00507650     History of Changes
Other Study ID Numbers: NR0008241
Study First Received: July 24, 2007
Last Updated: July 25, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Pressure ulcers
Nursing home
Fluid balance
Collagen deposition

Additional relevant MeSH terms:
Pressure Ulcer
Skin Diseases
Skin Ulcer processed this record on March 01, 2015