Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT04426032
Status:
COMPLETED
Last Update Posted:
2021-07-20
First Post:
2020-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Value of Doppler RSI for Prediction of AKI in Septic Patients in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D018805', 'term': 'Sepsis'}], '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': '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2020-06-09', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of AKI', 'timeFrame': '1 day at admission', 'description': 'incidence of AKI related to Renal resistive index.'}], 'secondaryOutcomes': [{'measure': 'APACHE III score', 'timeFrame': '1 day at admission', 'description': 'Acute Physiology and Chronic Health Evaluation scores. Score range (0 better - 299 worse)'}, {'measure': 'APACHE IV score', 'timeFrame': '1 day at admission', 'description': 'Acute Physiology and Chronic Health Evaluation scores. Score range (0 better - 286 worse)'}, {'measure': 'SOFA score', 'timeFrame': '1 day at admission', 'description': 'Sequential Organ Failure Assessment (SOFA) score. Score Range (0 better - 24 worse)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Kidney Injury', 'Sepsis'], 'conditions': ['Acute Kidney Injury', 'Sepsis']}, 'descriptionModule': {'briefSummary': 'Acute kidney injury (AKI) Diagnosis is based on rising creatinine. Intrarenal vasoconstriction occurs earlier and measuring flow resistance in the renal circulation (Renal Resistive Index (RRI)) could become part of vital organ function assessment using Doppler ultrasound.\n\nThe aim of this study is to predict AKI in septic patients in ICU by measuring RRI on admission by comparing two groups of patients, first group with RRI of normal value (0.6-0.7) and the other group with high RRI more than 0.7 and both with normal renal function on admission.', 'detailedDescription': 'Patients who have criteria of sepsis, with normal renal function on admission will undergo Renal Doppler Ultrasound examination to measure Renal resistive index.\n\nPatients will be divided into 2 groups:\n\n1. Group (A) patients with renal resistive index between 0.6 and 0.7 (normal RRI).\n2. Group (B) patients with renal resistive index more than 0.7 (high RRI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of both sex admitted to ICU, with criteria of sepsis, and normal renal function on admission.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who have criteria of sepsis on admission which include two or more of SIRS which include: (Temperature \\>38°C or \\<36°C, Heart rate \\>90/min, Respiratory rate \\>20/min or PaCO2 \\<32mmHg (4.3kPa) and White blood cell count \\>12000/mm3 or \\<4000/mm3 or \\>10% immature bands.) in addition to suspected or confirmed infection.\n2. Patients who have normal renal function on admission.\n\nExclusion Criteria:\n\n1. Currently recovering from an AKI at the time of inclusion and Renal impairment on admission.\n2. Patients with obstructive renal failure, renal artery stenosis were excluded from this study.\n3. Patients on chemotherapy and/or radiotherapy.\n4. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT04426032', 'briefTitle': 'Predictive Value of Doppler RSI for Prediction of AKI in Septic Patients in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Predictive Value of Doppler Renal Resistive Index for Prediction of Acute Kidney Injury in Septic Patients in Intensive Care Unit.', 'orgStudyIdInfo': {'id': 'FMASU M S 299 / 2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with RRI between 0.6 and 0.7', 'description': 'Normal renal resistive index', 'interventionNames': ['Diagnostic Test: Renal Doppler Ultrasound']}, {'label': 'Patients with RRI more than 0.7', 'description': 'High renal resistive index', 'interventionNames': ['Diagnostic Test: Renal Doppler Ultrasound']}], 'interventions': [{'name': 'Renal Doppler Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of Renal resistive index', 'armGroupLabels': ['Patients with RRI between 0.6 and 0.7', 'Patients with RRI more than 0.7']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohamed Saleh Ahmed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of Anesthesia and Intensive Care'}, {'name': 'Mohammed Saeed Abdelaziz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Anesthesia and Intensive Care'}, {'name': 'Mona Refaat Hosney, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant Professor of Anesthesia and Intensive Care'}, {'name': 'Ahmed Abdelsattar Abuelmajd, MBBCH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Candidate of master degree in general intensive care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is not yet known if there will be a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia and Intensive Care', 'investigatorFullName': 'Mohamed Saleh Ahmed Massoud', 'investigatorAffiliation': 'Ain Shams University'}}}}