Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-27 @ 7:20 AM
Study NCT ID:
NCT00507650
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2007-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2007-07-24', 'studyFirstSubmitQcDate': '2007-07-25', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collagen deposition', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': 'Total body water', 'timeFrame': '10 days'}, {'measure': 'Safety - development of heart failure', 'timeFrame': 'Study duration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pressure ulcers', 'Geriatrics', 'Nursing home', 'Fluid balance', 'Collagen deposition'], 'conditions': ['Pressure Ulcers']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\nThose:\n\n* Who have or have had heart failure or renal failure/insufficiency\n* Who currently smoke\n* With acute illness or having experienced it in the last 7 days\n* Taking immunosuppressive drugs\n* With an implantable defibrillator\n* With a glycosylated hemoglobin of \\>8%\n* With a body mass index is \\<21 kg/m2 or \\> 30 kg/m2; and\n* Being treated for dehydration.'}, 'identificationModule': {'nctId': 'NCT00507650', 'briefTitle': 'Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Supplement Fluid & Collagen Deposition', 'orgStudyIdInfo': {'id': 'NR0008241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prescribed', 'description': 'Fluid volume and type prescribed by MD or provider.', 'interventionNames': ['Dietary Supplement: Fluid intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Supplemental', 'description': 'Fluid volume and type prescribed by physician or provider plus 10 ml/kg X 5 days.', 'interventionNames': ['Dietary Supplement: Fluid intervention plus 10 ml/kg/day']}], 'interventions': [{'name': 'Fluid intervention', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Volume of fluid prescribed by physician or provider/day X 5 days.', 'armGroupLabels': ['Prescribed']}, {'name': 'Fluid intervention plus 10 ml/kg/day', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Fluid volume and type prescribed by physician or provider plus 10 ml/kg/day X 5 days.', 'armGroupLabels': ['Supplemental']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nancy A. Stotts, RN, EdD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}