Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT06353659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Diagnostic Value of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU
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': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-07', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-04-07', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute kidney injury (according to KDIGO 2012 criteria)', 'timeFrame': 'Through study completion, an average of 7 days', 'description': 'Acute kidney injury occur or not'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intensive Care Unit', 'Acute Kidney Injury', 'Ultrasound']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to quantitatively assess the renal microcirculation changes by contrast-enhanced ultrasound (CEUS) and to obtain systemic hemodynamic information by ultrasound Doppler at the same time, to analyze the relationship between renal microcirculation changes and systemic hemodynamic changes, and to explore the diagnostic value of CEUS in critically ill acute kidney injury.', 'detailedDescription': 'The main questions it aims to answer are:\n\n1. To explore the quantitative parameters of contrast-enhanced ultrasound which can reflect the changes of renal microcirculation。\n2. To explore the relationship between renal microcirculation and systemic hemodynamics。\n3. To explore the value of quantitative evaluation of renal microcirculation changes by contrast-enhanced ultrasound in the diagnosis of acute kidney injury'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Through literature review, the latest meta-analysis results showed that the area under the curve of CEUS parameters for diagnosing AKI was 0.84 and the width of the confidence interval was 0.22. When α=0.05, the sample size N=54 was obtained by PASS software. Considering the 10% shedding rate, 60 patients were expected to be enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 years old\n* First admission to ICU \\< 24h after admission and expected ICU stay ≥48 hours\n* Acute kidney injury risk factors (KDIGO 2012)\n* Contrast-enhanced ultrasound\n\nExclusion Criteria:\n\n* Known severe chronic kidney disease (CKD≥ stage 4) or undergoing hemodialysis treatment\n* Kidney transplantation or renal malignancy\n* Terminal stage of malignant tumor\n* Pregnancy\n* Renal artery stenosis or renal vein thrombosis\n* The quality of CEUS images is poor, and quantitative analysis cannot be performed'}, 'identificationModule': {'nctId': 'NCT06353659', 'briefTitle': 'The Diagnostic Value of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'The Diagnostic Value of Contrast-enhanced Ultrasound in Acute Kidney Injury in Intensive Care Unit', 'orgStudyIdInfo': {'id': 'M2024077'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with acute kidney injury (AKI)', 'description': 'Patient diagnosed with AKI according to kidney disease improving global outcomes (KDIGO) 2012 criteria', 'interventionNames': ['Diagnostic Test: Contrast-enhanced Ultrasound']}, {'label': 'Patients without AKI', 'description': 'Patient diagnosed without AKI according to kidney disease improving global outcomes (KDIGO) 2012 criteria', 'interventionNames': ['Diagnostic Test: Contrast-enhanced Ultrasound']}], 'interventions': [{'name': 'Contrast-enhanced Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients with acute kidney injury high risk factors (KDIGO 2012) will undergo a contrast-enhanced ultrasound within 24 hours of admission to the ICU', 'armGroupLabels': ['Patients with acute kidney injury (AKI)', 'Patients without AKI']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yuewei Zhang, Dr', 'role': 'CONTACT', 'email': 'zhang_yue_wei@126.com', 'phone': '18800109082'}, {'name': 'Ligang Cui, Dr', 'role': 'CONTACT', 'email': 'cuiligang_bysy@126.com', 'phone': '13910627163'}], 'overallOfficials': [{'name': 'Ligang Cui, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ultrasound, Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Cui Ligang', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}