Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT06305403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VEXUS and NGAL in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood sample for blood ngal level'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '5 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-05-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-10', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ngal', 'timeFrame': 'first and fifth days', 'description': 'neutrophil gelatinase-associated lipocalin'}, {'measure': 'VEXUS', 'timeFrame': 'first and fifth days', 'description': 'venous excess ultrasound score (If VCI diameter is \\< 2 cm, there is no congestion. If the VExUS score is 0, and you do not need to proceed further. If VCI\\>2, congestion is present. Further examination is necessary to determine the severity of congestion and VExUS scores 1-3.Each of the hepatic, portal and renal veins are subsequently examined and classified as normal, mildly congested, or severely congested. The VExUS system has four grades: Grade 0 represents no congestion in any organ, Grade 1 represents only mild congestive findings, Grade 2 represents severe congestive findings in only one organ, and Grade 3 represents severe congestive findings in at least two out of three organ systems.'}], 'secondaryOutcomes': [{'measure': 'MORTALİTY', 'timeFrame': '28 days', 'description': '28 days mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ngal', 'vexus'], 'conditions': ['Sepsis', 'Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'In this prospective observational study, patients hospitalized in mixed intensive care unit, aged between 18 and 80, and diagnosed with sepsis and septic shock according to sepsis-3 criteria will be included.\n\nTo determine whether patients develop AKI during the first five days of ICU admission, creatinine and urine output will be monitored daily for the first five days of ICU admission according to KDIGO criteria. Clinical diagnosis and treatment of AKI will be made according to KDIGO.\n\nAccording to KDIGO, patients will be divided into two groups: those who develop AKI and those who do not.\n\nBy comparing plasma NGAL and VEXUS scores between groups, the sensitivity and specificity of the VEXUS score in determining AKI will be determined.', 'detailedDescription': "In this prospective observational study, patients hospitalized in mixed intensive care unit, aged between 18 and 80, and diagnosed with sepsis and septic shock according to sepsis-3 criteria will be included.\n\nPoor abdominal echogenicity, age \\< 18 years, other conditions causing shock (hypovolemic, cardiogenic, neurogenic), life expectancy less than 24 hours, pregnancy, vasospastic disease, intraperitoneal pressure \\> 15 mm Hg, obstructive renal failure or suspected renal artery Defined as the presence of stenosis, liver and kidney transplanted patients, liver and kidney tumors, patients receiving dialysis treatment, single kidney and other kidney abnormalities, right heart failure, acute mesenteric ischemia (GFR) \\< 30 ml/min/1.73m2. Those with severe acute or chronic renal failure will be excluded from the study.\n\nAfter patients are diagnosed with sepsis/septic shock, in accordance with the Surviving Sepsis 2021 guide; Cultures will be sent and antibiotics, fluids, and vasopressor treatment will be started if necessary. Standard monitoring of the patients (heart rate, mean arterial pressure, peripheral oxygen saturation) will be performed.\n\nTo determine whether patients develop AKI during the first five days of ICU admission, creatinine and urine output will be monitored daily for the first five days of ICU admission according to KDIGO criteria. Clinical diagnosis and treatment of ACI will be made according to KDIGO.\n\nAccording to KDIGO, patients will be divided into two groups: those who develop ACI and those who do not.\n\nBy comparing plasma NGAL and VEXUS scores between groups, the sensitivity and specificity of the VEXUS score in determining ACI will be determined.\n\nBlood samples for plasma NGAL level will be taken within the first 24 hours of sepsis diagnosis, after the patient has received one-hour bundle therapy and the patient has been stabilized. The VEXUS score will be measured simultaneously with ultrasound. Both parameters will be repeated after the 72nd hour.\n\nVEXUS score measurement will be performed by an experienced practitioner with a transparietal 2-5 MHz curvi-linear probe (Ch5-2 ultrasound transducer, Siemens Healthineers ACUSON NX3) and the values and graphs will be saved to external memory.\n\nFor plasma NGAL level, approximately 10 ml of blood samples taken from the peripheral vein will be centrifuged at 1500 rpm for 5 minutes and stored at -80 °C.\n\nPatients' age, gender, weight, height, body mass index, accompanying diseases (e.g., diabetes mellitus, hypertension, heart failure, COPD, cancer, anemia, poisonings, trauma), source and type of infection, procalcitonin, c-reactive protein (CRP), lactate, routine markers of circulation, central venous pressure, medications (diuretic, vasopressor, inotropic agent, antimicrobial, insulin, colloid, albumin use, blood and blood product transfusion), recent use of contrast material, fluid balance, renal replacement. The need for treatment, the need for mechanical ventilation treatment, the stage of the AKI group according to KDIGO, Acute Physiology and Chronic Health Evaluation (APACHE II) score, Sequential Organ Failure Assesment (SOFA) score, hospital stay and 28-day mortality will be recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'sepsis and septic shock in ICU', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sepsis septic shock\n\nExclusion Criteria:\n\n* Poor abdominal echogenicity,\n* other conditions causing shock (hypovolemic, cardiogenic, neurogenic),\n* life expectancy less than 24 hours, pregnancy, vasospastic disease, intraperitoneal pressure \\> 15 mm Hg, obstructive renal failure liver and kidney transplanted patients, liver and kidney tumors, patients receiving dialysis treatment, single kidney and other kidney abnormalities, right heart failure, acute mesenteric ischemia chronic renal failure'}, 'identificationModule': {'nctId': 'NCT06305403', 'briefTitle': 'VEXUS and NGAL in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'Comparison of Venous Excess Ultrasound Score (VExUS) With Neutrophil Gelatinase-associated Lipocalin (NGAL) in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury', 'orgStudyIdInfo': {'id': 'VEXUS1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with sepsis who develop AKI', 'interventionNames': ['Diagnostic Test: serum creatinin level']}, {'label': '2', 'description': 'Patients with sepsis who not develop AKI', 'interventionNames': ['Diagnostic Test: serum creatinin level']}], 'interventions': [{'name': 'serum creatinin level', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['urine output'], 'description': 'Serum creatinine and urine amounts will be checked for five days.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ayse B OZER', 'role': 'CONTACT', 'email': 'abelinozer@gmail.com', 'phone': '90-4223410660', 'phoneExt': '3107'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Intensive Care Unit', 'investigatorFullName': 'Ayse Belin Ozer', 'investigatorAffiliation': 'Inonu University'}}}}