Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT01436292
Status:
WITHDRAWN
Last Update Posted:
2022-11-17
First Post:
2011-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypoalbuminemia in Burn Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D034141', 'term': 'Hypoalbuminemia'}, {'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007019', 'term': 'Hypoproteinemia'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-15', 'studyFirstSubmitDate': '2011-07-14', 'studyFirstSubmitQcDate': '2011-09-16', 'lastUpdatePostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Organ dysfunction as assessed by a change in the SOFA score from baseline to day 7 (or before if the patient is discharged from the ICU or died).', 'timeFrame': 'Seven days'}], 'secondaryOutcomes': [{'measure': 'ICU and hospital mortality', 'timeFrame': '1, 3 and 6 months'}, {'measure': 'ICU and hospital length of stay', 'timeFrame': '1, 3 and 6 months'}, {'measure': 'Free days of mechanical ventilation', 'timeFrame': 'Seven days'}, {'measure': 'Caloric intake', 'timeFrame': 'Seven days'}, {'measure': 'Fluid balance', 'timeFrame': 'Seven days'}, {'measure': 'Incidence of infection', 'timeFrame': 'Seven days'}, {'measure': 'Time to complete coverage defined as the time between admission and last surgery for grafting', 'timeFrame': '1, 3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypoalbuminemia', 'Burns', 'Albumin', 'Organ dysfunction', 'Outcome'], 'conditions': ['Second or Third Degree Burns']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether 5% human albumin solution, given to correct hypoalbuminemia, could improve organ dysfunction in burn patients as assessed by a change in the SOFA score from baseline to day 7 (or before if the patient is discharged from the ICU or died).', 'detailedDescription': 'Each year approximately 2 million people are burned in the USA, from which 80,000 are hospitalized and 6,500 die. It is a well known fact that the two most important factors for mortality in burn patients are age and percent total body surface area burn (TBSA), which are unmodifiable findings.\n\nA predictable inflammatory response takes place after a burn injury leading to profound changes in patient homeostasis. As a result, hypoalbuminemia is one of the common finding in severe burn patients. 21% of hospitalized adult patients are hypoalbuminemic on admission. After admission, worsening of existing hypoalbuminemia and development of de novo one are frequently seen.\n\nMoreover, hypoalbuminemia, a potentially modifiable variable, has been strongly associated with poor clinical outcomes in critically ill patients and in burn patients.\n\nDynamic organ dysfunction scores have been introduced in critically ill patients few years ago in order to describe the evolution of patients on a daily basis. The Sequential Organ Failure Assessment (SOFA) score is now one of the most accepted score in critically ill patients and has been validated in general medico-surgical unit, as well as in trauma and cardiac surgery patients. It encompasses components assessing six organ functions. This score has also been shown to predict mortality in critically ill patients and in burn patients when used in a dynamic way.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients admitted to the BICU in the Centre hospitalier de l'Université de Montréal within 24 hours following their thermal burn injury.\n2. Patients with second or third degree burns greater or equal than 20% of total body surface area.\n3. Patients aged 18 years or older. -\n\nExclusion Criteria:\n\n1. Patients with serum albumin greater than 30 g/dl at the time of randomization.\n2. Patients with a do not resuscitate order.\n3. Patients needing total parenteral nutrition.\n4. Patients with the following chronic diseases that could affect baseline SOFA calculation or serum albumin levels: end-stage kidney disease, nephrotic syndrome, hepatitis, exudative enteropaty, chronic thrombocytopenia or hematological malignancy.\n5. Patients with a known reaction to albumin.\n6. Pregnant or lactating women.\n7. Patients younger than 18 years old. -"}, 'identificationModule': {'nctId': 'NCT01436292', 'acronym': 'Halburns', 'briefTitle': 'Hypoalbuminemia in Burn Patients', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Hypoalbuminemia in Burn Patients: Should we Care? - A Randomized Controlled Clinical Pilot Trial', 'orgStudyIdInfo': {'id': 'CE 10.239'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Albumin', 'description': 'Patient will receive 5% HAS daily for the first 7 days of stay in ICU according to their albumin level', 'interventionNames': ['Drug: 5% human albumin solution (HAS)']}], 'interventions': [{'name': '5% human albumin solution (HAS)', 'type': 'DRUG', 'description': 'Patient will receive 5% HAS daily for the first 7 days of stay in ICU according to their albumin level:\n\n≥ 30 gr/L: albumin will not be administered; 25 - 29.9 gr/L: 25 g of 5% HAS; 20 - 24.9 gr/L: 50 g 5% HAS; 15 - 19.9 gr/L: 75 g of 5% HAS; 10 - 14.9 gr/L: 100 g of 5% HAS; \\< 10 gr/L: 150 g of 5% HAS.', 'armGroupLabels': ['Albumin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2W 1T8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre hospitalier de l'Université de Montréal (CHUM)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Roberto Eljaiek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Montréal - CHUM'}, {'name': 'Marc-Jacques Dubois, MD - FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Montréal - CHUM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'collaborators': [{'name': "Centre de Recherche du Centre Hospitalier de l'Université de Montréal", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}