Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 3:14 AM
Study NCT ID:
NCT07417969
Status:
RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Effect of Albumin Combined With Furosemide in Critically Ill Patients With Fluid Overload: Impact on Urine Output and Renal Function"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009846', 'term': 'Oliguria'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005665', 'term': 'Furosemide'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D004232', 'term': 'Diuretics'}], 'ancestors': [{'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D045283', 'term': 'Natriuretic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study uses a double-blind design. Both participants and care providers are masked to treatment allocation. Patients are randomized in a 1:1 ratio to receive either furosemide 1 mg/kg plus placebo or furosemide 1 mg/kg plus 50 g of intravenous albumin. An independent staff member prepares the study solutions in identical opaque containers with equal volumes to preserve blinding.\n\nClinical evaluations, including urine output measurement at 2 hours and bedside ultrasound assessment of fluid overload, are performed without revealing the assigned group. Blinding is maintained throughout the study until data collection is complete and the database is locked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study uses a randomized, parallel-group design in which participants are assigned to one of two treatment arms: furosemide monotherapy or the combination of furosemide plus albumin. Each participant receives only one intervention throughout the study. Urine output is measured at 2 hours after administration, along with serum and urine biochemical markers, hemodynamic variables, and bedside ultrasound indicators of fluid overload. These outcomes are compared between groups to evaluate differences in diuretic response and renal function.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine output at 2 hours', 'timeFrame': '2 hours after administration of the study treatment.', 'description': 'Urine output measured in milliliters at 2 hours after administration of the assigned treatment (furosemide alone or furosemide plus albumin). Measurement performed with standard urine collection devices by blinded staff.'}], 'secondaryOutcomes': [{'measure': 'Ultrasound assessment of fluid overload', 'timeFrame': 'baseline to 2 hours', 'description': 'Bedside ultrasound evaluation of fluid overload, including inferior vena cava diameter and venous congestion patterns.'}, {'measure': 'Electrolyte changes (Na, K, Cl)', 'timeFrame': 'Baseline to 24 hours.', 'description': 'Change in serum sodium, potassium, and chloride concentrations from baseline to 24 hours.'}, {'measure': 'Change in serum creatinine', 'timeFrame': 'Baseline to 24 hours.', 'description': 'Change in serum creatinine from baseline to 24 hours after administration of the assigned treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['furosemide', 'albumin', 'fluid overload', 'diuretics', 'urine output'], 'conditions': ['Urine Output Decreased']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effectiveness of furosemide alone versus the combination of furosemide plus albumin in critically ill adult patients with fluid overload. The trial evaluates whether co-administration of albumin enhances diuretic response compared with standard furosemide therapy. The primary outcomes include urine output at 2 hours, changes in renal perfusion markers, and biochemical parameters. Secondary outcomes include changes in mean arterial pressure, electrolyte balance, and renal resistance index. The study seeks to determine whether adding albumin provides a clinically meaningful improvement in diuresis and renal function compared with furosemide monotherapy.', 'detailedDescription': 'This randomized clinical study evaluates two diuretic strategies for fluid overload in adult critically ill patients: furosemide monotherapy versus combined therapy with furosemide plus albumin. Albumin may enhance diuretic effectiveness by increasing intravascular oncotic pressure, improving renal perfusion, and facilitating drug delivery to the nephron.\n\nThe protocol includes standardized dosing, measurement of urine output at 2 hours, and analysis of serum and urine biochemical parameters. Bedside ultrasound will be used to assess markers of fluid overload, including evaluation of the inferior vena cava and venous congestion patterns. Hemodynamic variables, electrolyte changes, and estimated glomerular filtration rate will also be monitored.\n\nThe study aims to determine whether the co-administration of albumin provides a clinically meaningful improvement in diuretic response and renal function compared with furosemide monotherapy in critically ill patients with fluid overload.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults ≥ 18 years of age admitted to the intensive care unit (ICU) without mechanical ventilation.\n\nPatients for whom diuretic therapy will be initiated for the first time during the ICU stay due to clinical signs of fluid overload, as determined by the treating physician.\n\nExclusion Criteria:\n\nPatients or family members who refuse participation in the study.\n\nPatients receiving palliative care.\n\nPatients with kidney failure requiring renal replacement therapy.\n\nPatients currently participating in another clinical research protocol.\n\nPatients with clinical evidence of hypovolemia or dehydration.'}, 'identificationModule': {'nctId': 'NCT07417969', 'acronym': 'FANTASTIC', 'briefTitle': '"Effect of Albumin Combined With Furosemide in Critically Ill Patients With Fluid Overload: Impact on Urine Output and Renal Function"', 'organization': {'class': 'OTHER', 'fullName': 'Hospital H+ Queretaro'}, 'officialTitle': '"Comparison of Furosemide Versus Albumin Plus Furosemide in Increasing Urine Output in Critically Ill Patients: A Double-Blind Randomized Clinical Trial"', 'orgStudyIdInfo': {'id': 'CEI2024a-01V2'}, 'secondaryIdInfos': [{'id': 'FANTASTIC', 'type': 'REGISTRY', 'domain': 'FANTASTIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: Furosemide Monotherapy', 'description': 'Participants receive furosemide 1 mg/kg IV as a single dose infused over 30 minutes, plus placebo (normal saline).', 'interventionNames': ['Drug: Furosemide (Diuretic)']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Furosemide + Albumin', 'description': 'Participants receive furosemide 1 mg/kg IV together with 50 g of 25% albumin, infused over 30 minutes.', 'interventionNames': ['Drug: Furosemide plus albumin']}], 'interventions': [{'name': 'Furosemide plus albumin', 'type': 'DRUG', 'description': 'Furosemide 1 mg/kg IV administered together with 50 grams of 25% albumin (one vial), infused over 30 minutes.', 'armGroupLabels': ['Experimental: Furosemide + Albumin']}, {'name': 'Furosemide (Diuretic)', 'type': 'DRUG', 'description': 'Furosemide 1 mg/kg IV as a single dose, infused over 30 minutes, plus placebo (normal saline).', 'armGroupLabels': ['Active Comparator: Furosemide Monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26089', 'city': 'Querétaro City', 'state': 'Querétaro', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Alina Elizabeth Arechiga Casas, MD', 'role': 'CONTACT', 'email': 'alieliac26@gmail.com', 'phone': '+52 8781360564'}], 'facility': '76000', 'geoPoint': {'lat': 20.58806, 'lon': -100.38806}}], 'centralContacts': [{'name': 'Alina Elizabeth Arechiga Casas, MD', 'role': 'CONTACT', 'email': 'alieliac26@gmail.com', 'phone': '+52 8781360564'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jose J Zaragoza, MD MSc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator / Principal Investigator', 'investigatorFullName': 'Jose J Zaragoza, MD MSc', 'investigatorAffiliation': 'Hospital H+ Queretaro'}}}}