Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-03-02 @ 11:08 PM
Study NCT ID:
NCT02376712
Status:
UNKNOWN
Last Update Posted:
2015-03-03
First Post:
2015-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Value of Urinary Indices in Differentiating Pre-renal and Renal Acute Kidney Injury
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'lastUpdateSubmitDate': '2015-03-02', 'studyFirstSubmitDate': '2015-02-25', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Diagnostic value of urinary indices in the subgroup of patients without diuretic use', 'timeFrame': 'At ICU admission and during ICU stay', 'description': 'The same strategy as the primary outcome will be used in subgroup of patients without diuretic use.'}, {'measure': 'Diagnostic value of urinary indices in the subgroup of patients without sepsis', 'timeFrame': 'At ICU admission and during ICU stay', 'description': 'The same strategy as the primary outcome will be used in subgroup of patients without sepsis.'}], 'primaryOutcomes': [{'measure': 'Diagnostic value of urinary indices in differentiating pre-renal and renal AKI', 'timeFrame': 'At ICU admission and during ICU stay', 'description': 'Urinary indices will be compared between patient groups (pre-renal and renal AKI). Sensitivity analysis will be applied to the cut off values of renal blood flow measured by TEE. Sensitivity and specificity of the indices will be calculated. Receiver operating characteristic curves will be plotted.'}], 'secondaryOutcomes': [{'measure': 'Feasibility of measuring renal blood flow among critically ill patients', 'timeFrame': 'At ICU admission and during ICU stay', 'description': 'Feasibility includes rate of success of measurement, intra-observer variability, inter-observer variability, and intraclass correlation coefficients.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Kidney Injury', 'Differential diagnosis', 'Urinary indices', 'Renal Blood Flow', 'Transesophageal Echocardiography'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the diagnostic value of urinary indices in differentiating pre-renal and renal acute kidney injury among critically ill patients.', 'detailedDescription': "Critically ill patients with acute kidney injury (AKI) will be included. Urinary indices will be obtained immediately after defining AKI, including specific gravity (SG), urine osmolarity (Uosm), urine sodium (UNa), fractional excretion of sodium (FENa), and fractional excretion of urea (FEurea).\n\nThe patterns of renal function and hemodynamic status serve as the clinical definition of pre-renal and renal AKI. Hemodynamic status will be evaluated at inclusion and followed during patients' ICU stay. Those who are hemodynamically stable at inclusion are classified as renal AKI. Those who are hemodynamically unstable at inclusion are followed until hemodynamic stabilization. Those with AKI recovery after hemodynamic stabilization are classified as pre-renal AKI. Those without AKI recovery are defined as renal AKI.\n\nUrinary indices are measured again after hemodynamic stability. One of the investigators objectives is to evaluate the diagnostic value of urinary indices using recovery of renal function after hemodynamic stabilization as the definition of pre-renal AKI.\n\nTransesophageal echocardiography (TEE) has been proved to be a reliable method of measuring left renal blood flow during surgical operation. Decreased renal blood flow measured by TEE may serve as an objective definition of pre-renal AKI. The mesurement will be conducted at inclusion if the patient is sedated, intubated, and without TEE contraindication. If the patient is hemodynamically unstable at inclusion, the measurement will be repeated after hemodynamic stabilization. The investigators study also serves the following aims: (1) feasibility of measuring renal blood flow by TEE among critically ill patients; (2) the correspondence between renal blood flow measured by TEE and clinical definition of pre-renal and renal AKI; (3) the diagnostic value of urinary indices in differentiating pre-renal and renal AKI, which is judged by renal blood flow measured by TEE."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed acute kidney injury at ICU admission or during ICU stay', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients admitted to Medical ICU of PUMCH with one of the following:\n\n* Increase in serum creatinine by ≥ 26.5 umol/l within 48 hours;\n* Increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days;\n* Urine volume \\< 0.5ml/kg/h for 1 hour.\n\nExclusion Criteria:\n\n* Obstructive renal disease\n* Renal replacement therapy (RRT) for chronic kidney disease'}, 'identificationModule': {'nctId': 'NCT02376712', 'briefTitle': 'Diagnostic Value of Urinary Indices in Differentiating Pre-renal and Renal Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'orgStudyIdInfo': {'id': 'MICU2015-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre-renal AKI', 'description': 'Three definitions of pre-renal AKI will be used separately:\n\n1. Hemodynamic instability (any sign of tissue hypoperfusion) on AKI identification, and AKI recovery in 24-72 hours following hemodynamic stabilization.\n2. AKI recovery in less than 72 hours after AKI identification.\n3. Decreased renal blood flow measured by transesophageal echocardiography (TEE).'}, {'label': 'Renal AKI', 'description': 'Three definitions of renal AKI will be used separately:\n\n1. Hemodynamically stable at AKI identification; or hemodynamically instability (any sign of tissue hypoperfusion) on AKI identification, and AKI persistence in 24-72 hours following hemodynamic stabilization.\n2. AKI persistence 72 hours after AKI identification.\n3. Normal or increased renal blood flow measured by TEE.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Du, Dr', 'role': 'CONTACT', 'email': 'dubin98@gmail.com', 'phone': '(8610)69155036'}], 'facility': 'MICU of Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Bin Du, Dr', 'role': 'CONTACT', 'email': 'dubin98@gmail.com', 'phone': '8610-69155036'}], 'overallOfficials': [{'name': 'Bin Du, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MICU of Peking Union Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Medical ICU', 'investigatorFullName': 'Bin Du', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}