Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers

NCT00507650 | Completed DMC

• 1 other identifier: NR0008241
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pressure Ulcers

Keywords

Pressure ulcers; Geriatrics; Nursing home; Fluid balance; Collagen deposition

Outcome Measures

Primary Outcomes (1)

• Collagen deposition

  10 days

Secondary Outcomes (2)

• Total body water

  10 days

• Safety - development of heart failure

  Study duration

Study Arms (2)

Prescribed

ACTIVE COMPARATOR

Fluid volume and type prescribed by MD or provider.

Dietary Supplement: Fluid intervention

Supplemental

EXPERIMENTAL

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

Interventions

Fluid intervention DIETARY_SUPPLEMENT

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

Prescribed

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.

Supplemental

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nancy A. Stotts, RN, EdD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2007
• First Posted: July 26, 2007
• Study Start: September 1, 2003
• Study Completion: March 1, 2007
• Last Updated: March 6, 2015

Record last verified: 2015-03