Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 6:42 AM
Study NCT ID:
NCT05240833
Status:
UNKNOWN
Last Update Posted:
2022-02-15
First Post:
2022-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VExUS-guided Fluid Management in Patients With Acute Kidney Injury in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-04', 'studyFirstSubmitDate': '2022-02-04', 'studyFirstSubmitQcDate': '2022-02-04', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal replacement therapy', 'timeFrame': 'Day 28', 'description': 'Number of days free from renal replacement therapy during the first 28 days'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Day 28'}, {'measure': 'KDIGO category for AKI', 'timeFrame': '48 hours', 'description': 'Variation in Kidney Disease: Improving Global Outcomes (KDIGO) criteria for AKI after 48 hours. Reducing the KDIGO category is a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury', 'Renal Insufficiency, Acute', 'Kidney; Disease, Acute', 'Critical Illness', 'Volume Overload', 'Fluid Overload']}, 'descriptionModule': {'briefSummary': 'A quasi experimental study that aims to verify whether the incorporation of VExUS in patients with AKI in the Intensive Care Unit (ICU) may prompt tailored interventions to increases the number of days free from Renal Replacement Therapy (RRT) during the first 28 days.', 'detailedDescription': 'Fluid overload is associated with organ dysfunction, such as Acute Kidney Injury (AKI), and increased mortality. It remains unclear if fluid overload is merely an epiphenomenon in critically ill patients or if organ congestion is a mediator of complications. Considering AKI related to fluid overload, diuretic therapy would reduce venous congestion and improve renal blood flow. The Venous Excess Ultrasound score (VExUS) identifies clinically significant venous congestion and indicates a high risk of post-operative AKI. This quasi-experimental study aims to verify whether the incorporation of VExUS in patients with AKI in the Intensive Care Unit (ICU) may prompt tailored interventions to increases the number of days free from Renal Replacement Therapy (RRT) during the first 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-elective ICU admission\n* Severe acute kidney injury (AKI) defined either: A ≥ 2-fold increase in serum creatinine from a known pre-morbid baseline or during the current hospitalization OR Urine output \\< 6.0 mL/kg over the preceding 12 hours\n\nExclusion Criteria:\n\n* Life-threatening indication of RRT (defined as intractable hyperkalaemia, acidosis, uraemic symptoms) at Day 0\n* RRT before recruitment\n* Use of Extracorporeal membrane oxygenation (ECMO)\n* Hepatic cirrhosis or other condition with portal hypertension\n* Lack of commitment to provide RRT as part of limitation of ongoing life support\n* Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate \\< 30 mL/min/1.73 m2 or chronic RRT\n* Refusal to sign the informed consent form'}, 'identificationModule': {'nctId': 'NCT05240833', 'acronym': 'AKIVEX', 'briefTitle': 'VExUS-guided Fluid Management in Patients With Acute Kidney Injury in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'VExUS-guided Fluid Management in Patients With Acute Kidney Injury in the Intensive Care Unit', 'orgStudyIdInfo': {'id': '2021-0487'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VExUS-Guided Arm', 'description': "VExUS results will be available for the treating physician. Patients will be treated according to current clinical practice. The use of diuretic and diuretic dosage will depend on treating physician's criteria.", 'interventionNames': ['Diagnostic Test: VExUS Score']}], 'interventions': [{'name': 'VExUS Score', 'type': 'DIAGNOSTIC_TEST', 'description': 'The VExUS-Guided Arm care team will be informed of the Day 0 VExUS immediately after the ultrasound is performed and given a suggested target for the following 48 hours as follows:\n\n* VExUS 0: There is no evidence of venous congestion.\n* VExUS 1: There is evidence of mild venous congestion. The investigators recommend targeting a net neutral or negative fluid balance with diuresis.\n* VExUS 2-3: There is evidence of moderate to severe venous congestion. The investigators recommend targeting a fluid balance of negative 1-2L with diuresis.\n* If the investigator cannot obtain ultrasound images of sufficient quality to calculate VExUS, the care team will be informed that there is no recommendation for that subject on that day.', 'armGroupLabels': ['VExUS-Guided Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'MARCIO M BONIATTI, PhD', 'role': 'CONTACT', 'email': 'mboniatti@hcpa.edu.br', 'phone': '+55 (51) 3359.8000'}, {'name': 'MARCOS F RIHL, MD', 'role': 'CONTACT', 'email': 'marcosrihl@gmail.com', 'phone': '+55 (51) 3359.8000'}, {'name': 'MARCIO M BONIATTI, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'MARCOS F RIHL, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'MARCIO M BONIATTI, PhD', 'role': 'CONTACT', 'email': 'mboniatti@hcpa.edu.br', 'phone': '+55 (51) 3359.8000'}, {'name': 'MARCOS F RIHL, MD', 'role': 'CONTACT', 'email': 'marcosrihl@gmail.com', 'phone': '+55 (51) 3359.8000'}], 'overallOfficials': [{'name': 'MARCIO M BONIATTI, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clínicas de Porto Alegre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}