Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers

Supplement Fluid & Collagen Deposition

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcers
• Intervention / Treatment: Dietary supplement: Fluid intervention; Dietary supplement: Fluid intervention plus 10 ml/kg/day

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 plus 10 ml/kg/day; Fluid volume and type prescribed by physician or provider plus 10 ml/kg/day X 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Collagen deposition	10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Total body water	10 days
Safety - development of heart failure	Study duration

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Nancy A. Stotts, RN, EdD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: July 24, 2007
• First Submitted That Met QC Criteria: July 25, 2007
• First Posted (Estimate): July 26, 2007

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 5, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Geriatrics; Fluid balance; Nursing home; Pressure ulcers; Collagen deposition
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: NR0008241