Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-02-02 @ 9:44 PM
Study NCT ID:
NCT03675633
Status:
UNKNOWN
Last Update Posted:
2021-02-24
First Post:
2018-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-22', 'studyFirstSubmitDate': '2018-09-15', 'studyFirstSubmitQcDate': '2018-09-17', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of FEUrea in different types of AKI in liver cirrhosis', 'timeFrame': 'baseline', 'description': 'measurement of FEUrea in different types of AKI in decompansated liver cirrhosis to identify its cause'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '30041275', 'type': 'BACKGROUND', 'citation': 'Piano S, Brocca A, Angeli P. Renal Function in Cirrhosis: A Critical Review of Available Tools. Semin Liver Dis. 2018 Aug;38(3):230-241. doi: 10.1055/s-0038-1661372. Epub 2018 Jul 24.'}, {'pmid': '29023314', 'type': 'BACKGROUND', 'citation': 'Durand F, Olson JC, Nadim MK. Renal dysfunction and cirrhosis. Curr Opin Crit Care. 2017 Dec;23(6):457-462. doi: 10.1097/MCC.0000000000000457.'}, {'pmid': '28533910', 'type': 'BACKGROUND', 'citation': 'Bucsics T, Krones E. Renal dysfunction in cirrhosis: acute kidney injury and the hepatorenal syndrome. Gastroenterol Rep (Oxf). 2017 May;5(2):127-137. doi: 10.1093/gastro/gox009. Epub 2017 Apr 24.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the diagnostic performance of FEUrea for the differential diagnosis of AKI in patients with cirrhosis and ascites Specifically, the ability of FEUrea to distinguish between ATN versus Pre renal azotemia and HRS.', 'detailedDescription': 'AKI according to KDIGO guidelines is defined as the followings:\n\n* An increase in serum creatinine by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 h\n* An increase in serum creatinine to ≥1.5 times baseline within the previous 7 days\n* Urine volume ≤0.5 ml/kg/h for 6 h Serum creatinine overestimates renal function in cirrhotic patients due to a number of factors: Creatinine production in patients with cirrhosis is reduced due to muscle wasting, there is an increased secretion of creatinine in the renal tubules, sCr may be diluted due to an increased volume of distribution, and finally, high bilirubin levels may interfere with the assays to measure its level. Recently, the International Club of Ascites (ICA) has adopted the concept of AKI which was developed originally to be used in general critically-ill patients. AKI is defined as the increase of at least 0.3 mg/dL (26 μmol/L) and/or ≥ 50% from baseline, within 48 hours Since urea absorption is largely modulated in the proximal tubules, it is not affected by diuretics acting more distally. The investigators therefore hypothesized that the fractional excretion of urea (FEUrea) could serve as a clinical aid in making an early distinction between ATN versus Pre renal azotemia and HRS type 1 in patients with cirrhosis and ascites presenting with AKI Fractional excretion of urea (FEUrea) (\\[urine urea nitrogen/ blood urea nitrogen)/(urine creatinine/plasma creatinine)\\] X 100) \\< 35% is specific for prerenal azotemia, and \\> 50% is specific for ATN'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'compensated and decompensated rrhotic patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver cirrhosis of any etiology diagnosed by clinical parameters involving laboratory tests, endoscopic or radiologic evidence of cirrhosis,\n* History of decompensation (hepatic encephalopathy, ascites, variceal bleeding, jaundice)\n* Age greater than 18 years\n* Presence of moderate or severe ascites\n\nExclusion Criteria:\n\nPatients excluded from analysis were those who did not meet inclusion criteria as well as the following\n\n* Prior liver or kidney transplant,\n* Advanced chronic kidney disease G4(GFR category grade 4) according to KDIGO guidelines.\n* Patients on acute or chronic renal replacement therapy,\n* Ambiguous diagnosis of AKI and phenotype of AKI,\n* Patients with hepatocellular carcinoma.'}, 'identificationModule': {'nctId': 'NCT03675633', 'briefTitle': 'Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Fractional Excretion of Urea: an Excellent Simple Tool for the Differential Diagnosis of Acute Kidney Injury in Liver Cirrhosis', 'orgStudyIdInfo': {'id': 'FEUrea in liver cirrhosis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FEUrea in decompensated liver cirrhosis', 'description': 'FEUrea for the differential diagnosis of AKI in patients with cirrhosis and ascites Specifically, the ability of FEUrea to distinguish between ATN versus Pre renal azotemia and HRS', 'interventionNames': ['Diagnostic Test: FEUrea']}], 'interventions': [{'name': 'FEUrea', 'type': 'DIAGNOSTIC_TEST', 'description': 'FEUrea in decompansated liver cirrhosis', 'armGroupLabels': ['FEUrea in decompensated liver cirrhosis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nermeen Mobarez, specialist', 'role': 'CONTACT', 'email': 'nermeenmobarez@gmail.com', 'phone': '00201098800485'}, {'name': 'Essam Abdel Aziz, lecturer', 'role': 'CONTACT', 'email': 'essam.nephro@gmail.com', 'phone': '00201009699081'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Nermeen mahmoud mobarez', 'investigatorAffiliation': 'Assiut University'}}}}