Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 10:57 PM
Study NCT ID:
NCT06924294
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pattern and Short Term Outcomes of Renal Affection in Patients With Liver Cirrhosis in Al-Rajhi Liver Hospital
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': 290}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-04-10', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': 'Through the study completion , average 6 months', 'description': 'Mortality during hospital stay'}, {'measure': 'Phenotypes of acute kidney injury across geographic areas', 'timeFrame': 'Baseline ( at admission ), then through the study completion, average 6 months', 'description': 'Characteristics of acute kidney injury (clinical type and stage)'}], 'secondaryOutcomes': [{'measure': '28-day mortality', 'timeFrame': '28 days', 'description': 'Mortality at 28 days'}, {'measure': 'Resolution of AKI', 'timeFrame': 'Hospital stay (up to 90 days)', 'description': 'Resolution of AKI will be defined as return of serum creatinine to a value within 0.3 mg/di (26.5 mmol/L) of the baseline value. Partial response will be defined as regression of AKI to a lower stage with a reduction of serum creatinine to ≥0.3 mg/d\\| (26.5 mmol/L) above the baseline value'}, {'measure': 'Development of CKD', 'timeFrame': '90 days', 'description': 'Chronic kidney disease will be defined as an estimated glomerular filtration rate \\<60 ml/min ml/min/1.73 m2 for \\>3 months. The Modification of Diet in Renal Disease equation will be used for estimating glomerular filtration rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['renal affection in patients with liver cirrhosis'], 'conditions': ['Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '25032185', 'type': 'BACKGROUND', 'citation': 'Choi YJ, Kim JH, Koo JK, Lee CI, Lee JY, Yang JH, Ko SY, Choe WH, Kwon SY, Lee CH. Prevalence of renal dysfunction in patients with cirrhosis according to ADQI-IAC working party proposal. Clin Mol Hepatol. 2014 Jun;20(2):185-91. doi: 10.3350/cmh.2014.20.2.185. Epub 2014 Jun 30.'}, {'pmid': '31384350', 'type': 'BACKGROUND', 'citation': 'Duah A, Nkrumah KN. Prevalence and predictors for spontaneous bacterial peritonitis in cirrhotic patients with ascites admitted at medical block in Korle-Bu Teaching Hospital, Ghana. Pan Afr Med J. 2019 May 16;33:35. doi: 10.11604/pamj.2019.33.35.18029. eCollection 2019.'}], 'seeAlsoLinks': [{'url': 'https://GoogleScholar.com', 'label': 'https://scholar.google.com/scholar\\_lookup?journal=Clinical%20and%20Molecular%20Hepatology\\&title=Prevalence%20of%20renal%20dysfunction%20in%20patients%20with%20cirrhosis%20according%20to%20ADQI-IAC%20working%20party%20proposal\\&author=Y.%20J.%20Choi\\&author'}]}, 'descriptionModule': {'briefSummary': '* To characterize the pattern and the prevalence of renal affection among liver cirrhosis patients.\n* To evaluate the short-term outcomes of those patients.', 'detailedDescription': 'Liver cirrhosis is a chronic liver disease characterized by significant scarring and dysfunction. One of its common complications is renal affection , which can significantly impact patient outcomes .\n\nAetiology of AKI can be categorized into three main types. These are prerenal (results from decreased renal perfusion), intrinsic renal (acute tubular necrosis), and postrenal AKI. In patients on admission, acute tubular necrosis is a common type of intrinsic AKI .\n\nThe development of portal hypertension in patients with liver cirrhosis leading to a reduction in systemic vascular resistance as a result of primary arterial vasodilation in the splanchnic circulation is the primary cause of AKI in cirrhotics. This mechanism primarily leads to hepatorenal syndrome. In addition, the underlying causes of liver cirrhosis can be the cause of intrinsic renal disease .\n\nEarly identification and management of AKI may improve outcomes. AKI in patients with liver cirrhosis in Egypt and their impact on inpatient mortality are largely unknown. This study was aimed at determining the prevalence, precipitating factors, predictors, and in-hospital mortality of AKI in patients with liver cirrhosis admitted at Al-Rajhi liver hospital at Egypt .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with liver cirrhosis admitted to the department .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with liver cirrhosis admitted to the department .\n\nExclusion Criteria:\n\n1. Patients with known preexisting chronic kidney disease according to KDIGO and EASL 2018 definitions ( defined as functional GFR \\<60 ml/min per 1.73 m 2 for ≥3 months or structural kidney damage for ≥3 months ).\n2. Patient refusal to give informed consent ( or his first degree relatives in case of disturbed conscious level).'}, 'identificationModule': {'nctId': 'NCT06924294', 'briefTitle': 'Pattern and Short Term Outcomes of Renal Affection in Patients With Liver Cirrhosis in Al-Rajhi Liver Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Pattern and Short Term Outcomes of Renal Affection in Patients With Liver Cirrhosis in Al-Rajhi Liver Hospital', 'orgStudyIdInfo': {'id': 'liver cirrhosis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'liver cirrhosis admitted to Al-Rajhi liver hospital', 'description': 'observation of renal affection in patients known to have liver cirrhosis', 'interventionNames': ['Other: observation of renal affection in patients with liver cirrhosis']}], 'interventions': [{'name': 'observation of renal affection in patients with liver cirrhosis', 'type': 'OTHER', 'description': '* CBC\n* Liver function test\n* kidney function test (serum creatinine, BUN, eGFR (EPI equation and MDRD equation) ,\n* Prothrombin time and concentration, INR,\n* Serum electrolytes\n* Urine analysis.', 'armGroupLabels': ['liver cirrhosis admitted to Al-Rajhi liver hospital']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'state': 'Assuit', 'country': 'Egypt', 'contacts': [{'name': 'Al-Rajhi liver hospital', 'role': 'CONTACT', 'email': 'info@rlh-egy.com', 'phone': '088208105'}], 'facility': 'Al-Raghi liver hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mohamed Omar Abd El-Malek, professor', 'role': 'CONTACT', 'email': 'Omar7619@aun.edu.eg', 'phone': '0201007343214'}], 'overallOfficials': [{'name': 'Mohamed Omar Abd El-Malek, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ahmed Radwan Riad', 'investigatorAffiliation': 'Assiut University'}}}}