Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-31 @ 3:00 AM
Study NCT ID:
NCT05866250
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2023-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Change of Doppler-based Renal Resistive Index in Predicting Renal Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 467}, 'targetDuration': '28 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-14', 'studyFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2023-05-10', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prognosis of AKI', 'timeFrame': '72 hours', 'description': 'NO AKI, transient AKI, persistent AKI. Transient AKI refers to the reduction in AKI stage ( (a decrease of serum creatinine, reversal of oliguria without diuretic therapy, and without need for renal replacement therapy) occurring with 72 hour after ICU admission. Persistent AKI refers to AKI without recovery occurring within 72 hours after ICU admission.'}], 'secondaryOutcomes': [{'measure': 'Recovery of kidney function', 'timeFrame': '28 days', 'description': 'A decrease of serum creatinine, reversal of oliguria without diuretic therapy, and without need for renal replacement therapy.'}, {'measure': 'Mortality', 'timeFrame': '28 days', 'description': 'Death or suivival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute kidney injury', 'renal resistive index', 'prognosis', 'critically ill patients'], 'conditions': ['Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '26162677', 'type': 'BACKGROUND', 'citation': 'Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.'}, {'pmid': '20862450', 'type': 'BACKGROUND', 'citation': 'Darmon M, Schortgen F, Vargas F, Liazydi A, Schlemmer B, Brun-Buisson C, Brochard L. Diagnostic accuracy of Doppler renal resistive index for reversibility of acute kidney injury in critically ill patients. Intensive Care Med. 2011 Jan;37(1):68-76. doi: 10.1007/s00134-010-2050-y. Epub 2010 Sep 23.'}, {'pmid': '34678845', 'type': 'BACKGROUND', 'citation': 'Saade A, Bourmaud A, Schnell D, Darmon M; R2D2 Study Group. Performance of Doppler-Based Resistive Index and Semiquantitative Renal Perfusion in Predicting Persistent Acute Kidney Injury According to Operator Experience: Post Hoc Analysis of a Prospective Multicenter Study. Crit Care Med. 2022 Apr 1;50(4):e361-e369. doi: 10.1097/CCM.0000000000005372.'}, {'pmid': '35074631', 'type': 'BACKGROUND', 'citation': 'Schnell D, Bourmaud A, Reynaud M, Rouleau S, Merdji H, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Darmon M. Performance of renal Doppler to predict the occurrence of acute kidney injury in patients without acute kidney injury at admission. J Crit Care. 2022 Jun;69:153983. doi: 10.1016/j.jcrc.2021.12.017. Epub 2022 Jan 21.'}, {'pmid': '30291377', 'type': 'BACKGROUND', 'citation': 'Darmon M, Bourmaud A, Reynaud M, Rouleau S, Meziani F, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Schnell D. Performance of Doppler-based resistive index and semi-quantitative renal perfusion in predicting persistent AKI: results of a prospective multicenter study. Intensive Care Med. 2018 Nov;44(11):1904-1913. doi: 10.1007/s00134-018-5386-3. Epub 2018 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to observe the correlation between dynamic changes in the Doppler-based renal resistive index (RI) and the occurrence of persistent acute kidney injury (AKI) in critically ill patients. The main questions it aims to answer are:\n\n* Are dynamic changes of RI within 24 or 48 hours associated with the prognosis of AKI (NO AKI, transient AKI, persistent AKI)?\n* what are the influencing factors of changes in RI? Participants will measure values of RI in patients at admission (0 hour), after 24 hours and after 48 hours, respectively, and collect characters such as age, sex, vital signs, Apache II, diagnosis, renal function, applied drugs, fluid, 72-hour renal function and renal replacement, followed renal replacement and the mortality rate at 28 days.', 'detailedDescription': 'NO AKI is defined as No AKI occurred within 72 hour after ICU admission; Transient AKI is defined as AKI with recovery, which refers to the reduction in AKI stage ( (i.e., a decrease of serum creatinine, reversal of oliguria without diuretic therapy, and without need for renal replacement therapy) occurring with 72 hour after ICU admission; Persistent AKI is defined as AKI without recovery occurring with 72 hour after ICU admission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All the critically ill patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Patients admitted to the ICU within 24 h of admission.\n\nExclusion Criteria:\n\n* Chronic kidney disease stage III-V;\n* History of kidney transplantation;\n* Previously known renal artery stenosis or renal vein thrombosis；\n* Cardiac arrhythmia precluding renal Doppler measurement;\n* Expected hospital stay \\< 72 h；\n* Pregnant patients\n* Last, patients with hospital stays \\< 72 h, since they could not be classified as having transient or persistent AKI according to our definitions, were secondarily excluded.'}, 'identificationModule': {'nctId': 'NCT05866250', 'acronym': 'DRRRI', 'briefTitle': 'Dynamic Change of Doppler-based Renal Resistive Index in Predicting Renal Recovery', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'Dynamic Change of Doppler-based Renal Resistive Index in Predicting Renal Recovery From Acute Kidney Injury in Critically Ill Patients: a Prospective Observational Multicenter Study', 'orgStudyIdInfo': {'id': 'DongZhang'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'critically ill patients', 'description': 'All newly admitted ICU patients', 'interventionNames': ['Diagnostic Test: Doppler-based renal resistive index']}], 'interventions': [{'name': 'Doppler-based renal resistive index', 'type': 'DIAGNOSTIC_TEST', 'description': "The kidney's interlobular or arcuate artery was preferentially selected and measured by pulse-wave Doppler.", 'armGroupLabels': ['critically ill patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130021', 'city': 'Changchun', 'state': 'Jlin', 'country': 'China', 'facility': "Jilin Province People's Hospital", 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jlin', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jlin', 'country': 'China', 'facility': 'The Third Affiliated Hospital of Changchung University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '133799', 'city': 'Dunhua', 'state': 'Jlin', 'country': 'China', 'facility': 'Dunhua City Hospital', 'geoPoint': {'lat': 43.36954, 'lon': 128.22861}}, {'zip': '132011', 'city': 'Jilin', 'state': 'Jlin', 'country': 'China', 'facility': 'Jilin Central Hospital', 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}, {'zip': '135099', 'city': 'Meihekou', 'state': 'Jlin', 'country': 'China', 'facility': 'Meihekou Central Hospital', 'geoPoint': {'lat': 42.52869, 'lon': 125.67876}}, {'zip': '132011', 'city': 'Siping', 'state': 'Jlin', 'country': 'China', 'facility': "Jilin Siping Central People's Hospital", 'geoPoint': {'lat': 43.16143, 'lon': 124.37785}}], 'overallOfficials': [{'name': 'Dong Zhang, Director', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Hospital of Jilin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Dong Zhang', 'investigatorAffiliation': 'The First Hospital of Jilin University'}}}}