Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-02 @ 3:15 AM
Study NCT ID:
NCT04522635
Status:
COMPLETED
Last Update Posted:
2020-08-24
First Post:
2020-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000418', 'term': 'Albumins'}], 'ancestors': [{'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Patients will be randomized for a minimum of 4 and maximum of 6 consecutive dialysis sessions to one of two sequences:\n\n1. Sequence A: Albumin in sessions 1, 3 and 5 and saline in sessions 2, 4 and 6\n2. Sequence B: Saline in sessions 1, 3, 5 and albumin in sessions 2, 4 and 6 Dialysis Procedures (Standard of Care with the exception of Albumin which is additional and for research purposes only): All dialysis sessions will include standard procedures and monitoring. Dialysis prescriptions will be individualized for each patient and will be maintained through each of the 6 sessions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-20', 'studyFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fluid removal', 'timeFrame': 'during procedure', 'description': 'achieved fluid removal expressed as ml/kg/hour'}], 'secondaryOutcomes': [{'measure': 'hypotension', 'timeFrame': 'during procedure', 'description': 'cardiovascular complications, including hypotensive episodes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypotension During Dialysis', 'Fluid Overload']}, 'referencesModule': {'references': [{'pmid': '33407747', 'type': 'DERIVED', 'citation': 'Macedo E, Karl B, Lee E, Mehta RL. A randomized trial of albumin infusion to prevent intradialytic hypotension in hospitalized hypoalbuminemic patients. Crit Care. 2021 Jan 6;25(1):18. doi: 10.1186/s13054-020-03441-0.'}]}, 'descriptionModule': {'briefSummary': 'Hospitalized patients often suffer from an acute shutdown of kidney function secondary to infections, use of antibiotics, or use of intravenous contrast agents. This results in the accumulation of toxic substances and retention of fluid in the body. Dialysis techniques are often needed to manage these patients to remove the retained toxic substances and extra fluid and allow the kidney time to recover. The amount and duration of fluid accumulation have been associated with a higher risk of death and longer hospital stays. Correction of fluid overload with dialysis has been shown to be beneficial in improving the outcomes from these patients. Most patients are quite sick and often have low levels of a blood protein called albumin that makes them more prone to developing low blood pressure during dialysis and limits the ability of dialysis to remove solutes and fluid adequately. Often dialysis sessions are complicated by the development of low blood pressures and symptoms such as nausea, vomiting, and headaches that further compromises dialysis efficacy. In this study, the hypothesis that addition of intravenous albumin during the dialysis session will improve the ability to remove fluid and reduce the incidence of low blood pressure during dialysis thereby improving patient tolerance and the efficacy of the procedure will be tested. Patients with acute kidney failure or end-stage Renal Disease who need dialysis for fluid removal will be allocated to receive albumin or saline as intravenous fluids during individual dialysis sessions and information on how much fluid can be removed and how many complications occur in each session will be recorded. Dialysis sessions with albumin will be compared with those with saline alone to determine the benefit of adding albumin to the treatment. Information obtained from this study will allow physicians to manage patients requiring dialysis for acute kidney failure more effectively and help improve outcomes.', 'detailedDescription': 'This study will address the following questions:\n\nAIM 1: Can the utilization of intravenous albumin enhance the efficacy of fluid removal in hospitalized patients undergoing dialysis for AKI or ESRD.\n\nThe hypothesis to be tested:\n\n1. Addition of albumin solutions to dialysis therapy will enhance the efficacy of fluid removal (total amount of fluid removed)\n2. Albumin solutions will improve the efficiency of fluid removal by dialysis per unit time\n3. Albumin addition will reduce the time to achieving and maintaining fluid balance and correcting fluid overload.\n\nAIM 2: Can the utilization of IV albumin improve the safety of fluid removal during dialysis?\n\nThe hypothesis to be tested:\n\n1. Addition of albumin solutions will reduce the frequency of Intradialytic hypotension associated with fluid removal on dialysis.\n2. Albumin solutions given during dialysis will reduce the incidence and magnitude of myocardial stunning associated with fluid removal on dialysis\n3. Albumin solutions given during dialysis will reduce post-dialysis symptoms AIM 3: Does utilization of IV albumin improve the microcirculation in hospitalized patients undergoing fluid removal with dialysis?\n\nThe hypothesis to be tested:\n\n1. Patients with AKI or ESRD will have deranged microcirculatory profile as compared to normal\n2. During fluid removal with dialysis changes in microcirculation correlate with alterations in hemodynamics related to the rate and amount of fluid removal\n3. Utilization of IV albumin during dialysis will reduce the microcirculatory stress of fluid removal'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years old\n* need for intermittent hemodialysis during hospitalization\n* hypoalbuminemia (albumin\\<3g/dl)\n\nExclusion Criteria:\n\n* allergy to the components of albumin'}, 'identificationModule': {'nctId': 'NCT04522635', 'briefTitle': 'Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury', 'orgStudyIdInfo': {'id': '141779'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'albumin', 'description': 'albumin (100 ml of Grifols 25%) given intravenously at the start of IHD', 'interventionNames': ['Drug: (100 ml of Albumin 25%)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline', 'description': '0.9% sodium chloride (normal saline (NS)) given intravenously at the start of IHD', 'interventionNames': ['Drug: (100 ml of Albumin 25%)']}], 'interventions': [{'name': '(100 ml of Albumin 25%)', 'type': 'DRUG', 'otherNames': ['albumin'], 'description': 'single dose of 25g albumin (100 ml of Grifols 25%) given intravenously at the start of IHD', 'armGroupLabels': ['albumin', 'normal saline']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ravindra L Mehta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grifols Biologicals, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Emeritus', 'investigatorFullName': 'Ravindra Mehta', 'investigatorAffiliation': 'University of California, San Diego'}}}}