Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 5:19 PM
Study NCT ID:
NCT07073508
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2025-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Validity of the Evaluation of Renal Artery Duplex in Critically Ill Acute Kidney Injury Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal resistivity index (RRI)', 'timeFrame': '1 week post-procedure', 'description': 'The renal resistivity index (RRI) will be assessed in patients with acute kidney injury (AKI) who require intensive care unit (ICU) admission within 24 hours.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Validity', 'Renal Artery Duplex', 'Critically Ill Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the clinical relevance of renal artery duplex ultrasound in critically ill patients with acute kidney injury (AKI) in terms of the renal resistive index (RRI).', 'detailedDescription': 'Diagnosis of acute kidney injury (AKI) is based on rising creatinine as late phenomenon. Intrarenal vasoconstriction occurs earlier, so measuring flow resistance in the renal circulation, renal resistive index (RRI), could become part of vital organ function assessment using Doppler ultrasound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'One hundred patients admitted to the intensive care unit (ICU), all the studied populations will be diagnosed to have AKI, with no past medical history of chronic renal disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age \\>18 years.\n* Both sexes.\n* Patients within 24 hours after intensive care unit (ICU) admission.\n\nExclusion Criteria:\n\n* Patients presented with poor abdominal echogenicity.\n* Chronic kidney disease, especially with estimated creatinine clearance less than 30 ml/min/1.73m.\n* Patients with dialysis dependency.\n* Patients with renal transplantation.\n* Patients with known renal artery stenosis.\n* If there is a pregnancy.\n* Patients with any congenital kidney diseases as mono-kidney, anatomic kidney abnormalities.'}, 'identificationModule': {'nctId': 'NCT07073508', 'briefTitle': 'The Validity of the Evaluation of Renal Artery Duplex in Critically Ill Acute Kidney Injury Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Validity of the Evaluation of Renal Artery Duplex in Critically Ill Acute Kidney Injury Patients', 'orgStudyIdInfo': {'id': 'FMASU MD51/2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients diagnosed with acute kidney injury (AKI).', 'interventionNames': ['Other: Renal Artery Duplex']}], 'interventions': [{'name': 'Renal Artery Duplex', 'type': 'OTHER', 'description': 'Renal artery duplex will be performed to all patients in terms of renal resistivity index (RRI).', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud R Basiony, Master', 'role': 'CONTACT', 'email': 'mohamoud.rabie2014@gmail.com', 'phone': '00201094726393'}, {'name': 'Mohamed M Shokeir, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ashraf E Elagamy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amr M Abdou, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aya H Ahmed, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mahmoud R Basiony, Master', 'role': 'CONTACT', 'email': 'mohamoud.rabie2014@gmail.com', 'phone': '00201094726393'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.', 'investigatorFullName': 'Mahmoud rabie', 'investigatorAffiliation': 'Ain Shams University'}}}}