Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-05 @ 5:20 PM
Study NCT ID:
NCT00228657
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2005-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000418', 'term': 'Albumins'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-25', 'studyFirstSubmitDate': '2005-09-28', 'studyFirstSubmitQcDate': '2005-09-28', 'lastUpdatePostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients receiving 4% Albumin will have less incidence and reduced severity of pressure injuries.'}], 'secondaryOutcomes': [{'measure': 'Is there a difference in the incidence of pressure injuries between those patients resuscitated with 4% Albumin and patients resuscitated with 0.9% Sodium Chloride'}, {'measure': 'Is there a difference in the severity of pressure injuries between those patients resuscitated with 4% Albumin and patients resuscitated with 0.9% Sodium Chloride.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pressure Ulcer, Area', 'Pressure Ulcer, Grade', 'Albumin Level', 'Risk Score', 'Length of ICU Stay']}, 'referencesModule': {'references': [{'pmid': '10964183', 'type': 'BACKGROUND', 'citation': 'Anthony D, Reynolds T, Russell L. An investigation into the use of serum albumin in pressure sore prediction. J Adv Nurs. 2000 Aug;32(2):359-65. doi: 10.1046/j.1365-2648.2000.01484.x.'}, {'pmid': '2018614', 'type': 'BACKGROUND', 'citation': 'Hanan K, Scheele L. Albumin vs. weight as a predictor of nutritional status and pressure ulcer development. Ostomy Wound Manage. 1991 Mar-Apr;33:22-7. No abstract available.'}, {'pmid': '1578064', 'type': 'BACKGROUND', 'citation': 'Cullum N, Clark M. Intrinsic factors associated with pressure sores in elderly people. J Adv Nurs. 1992 Apr;17(4):427-31. doi: 10.1111/j.1365-2648.1992.tb01926.x.'}, {'pmid': '1568151', 'type': 'BACKGROUND', 'citation': 'Goodrich C, March K. From ED to ICU: a focus on prevention of skin breakdown. Crit Care Nurs Q. 1992 May;15(1):1-13. doi: 10.1097/00002727-199205000-00002. No abstract available.'}, {'pmid': '10386267', 'type': 'BACKGROUND', 'citation': 'Peerless JR, Davies A, Klein D, Yu D. Skin complications in the intensive care unit. Clin Chest Med. 1999 Jun;20(2):453-67, x. doi: 10.1016/s0272-5231(05)70152-0.'}, {'pmid': '2026044', 'type': 'BACKGROUND', 'citation': 'Kuhn MM. Colloids vs crystalloids. Crit Care Nurse. 1991 May;11(5):37-44, 46-51.'}]}, 'descriptionModule': {'briefSummary': 'Patients resuscitated with 4% Albumin will have less incidence and reduced severity of pressure injuries than patients resuscitated with 0.9% Sodium Chloride due to the improved intravascular oncotic pressure effected from higher albumin levels.', 'detailedDescription': 'Pressure ulcers incur multiple risks to the patient. The disruption of the skin is a portal of entry for infection , which may remain localised to the site or become blood borne. A pressure ulcer can lead to protein and fluid losses from the wound exudate. Many authors have theorised the existence of a relationship between the development of pressure ulcers and low serum albumin levels however, there is no strong evidence to prove this correlation. The literature does demonstrate a clear relationship between people with existing pressure ulcers and the presence of low serum albumins. Specifically serum albumin levels \\<30mg/dl have been associated with the incidence of pressure ulcer development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRandomisation to the SAFE study -\n\nExclusion Criteria:\n\nIn addition to the SAFE exclusion criteria, pre-existing pressure ulcers (developed prior to ICU admission) will also be excluded-'}, 'identificationModule': {'nctId': 'NCT00228657', 'briefTitle': 'Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bayside Health'}, 'officialTitle': 'The Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride Administration (Substudy of SAFE Protocol 153711)', 'orgStudyIdInfo': {'id': '137/99'}}, 'armsInterventionsModule': {'interventions': [{'name': '4% Albumin / 0.9% Sodium Chloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3181', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital, Prahran,', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Shena M Graham, BN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Alfred Hospital, Prahran, Melbourne, Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayside Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}