[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659268":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":36,"studyPopulation":37,"armGroups":38,"interventions":44,"overallOfficials":50,"centralContacts":58,"locations":68,"responsibleParty":89,"collaborators":32,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":32,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":32,"enrollmentInfo":101,"targetDuration":32,"studyType":104,"phases":32,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":114,"whyStopped":32,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Izmir Katip Celebi University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Area Under the Receiver Operating Characteristic Curve of the Renal Angina Index for Predicting KDIGO Stage 2 or Stage 3 Acute Kidney Injury","The predictive discrimination of the Renal Angina Index (RAI), calculated 24 hours after intensive care unit admission, for the development of Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 or stage 3 acute kidney injury (AKI) during the subsequent 48 hours will be assessed using the area under the receiver operating characteristic curve (AUROC), with a 95% confidence interval.\n\nThe target outcome will be development of KDIGO stage 2 or stage 3 AKI within 48 hours after RAI calculation. KDIGO stage 2 AKI will be defined as serum creatinine 2.0-2.9 times baseline or urine output \\\u003C0.5 mL\u002Fkg\u002Fhour for at least 12 hours. KDIGO stage 3 AKI will be defined as serum creatinine ≥3.0 times baseline, serum creatinine ≥4.0 mg\u002FdL in the setting of AKI, initiation of acute renal replacement therapy, urine output \\\u003C0.3 mL\u002Fkg\u002Fhour for at least 24 hours, or anuria for at least 12 hours. When more than one criterion is met, the highest KDIGO stage reached will determine AKI severity.","Within 48 hours after RAI calculation",[14,17,21,25,29],{"measure":15,"description":16,"timeFrame":12},"Development of KDIGO Stage 2 or Stage 3 Acute Kidney Injury Within 48 Hours After RAI Calculation","The number and proportion of participants who develop Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 or stage 3 acute kidney injury (AKI) during the 48-hour period following calculation of the Renal Angina Index (RAI) will be recorded.\n\nKDIGO stage 2 AKI will be defined by either of the following:\n\nSerum creatinine 2.0-2.9 times the baseline value; or\n\nUrine output \\\u003C0.5 mL\u002Fkg\u002Fhour for at least 12 hours.\n\nKDIGO stage 3 AKI will be defined by any of the following:\n\nSerum creatinine ≥3.0 times the baseline value;\n\nSerum creatinine ≥4.0 mg\u002FdL in the setting of acute kidney injury;\n\nInitiation of acute renal replacement therapy;\n\nUrine output \\\u003C0.3 mL\u002Fkg\u002Fhour for at least 24 hours; or\n\nAnuria for at least 12 hours.\n\nIf serum creatinine and urine-output criteria correspond to different KDIGO stages, the highest stage reached will determine AKI severity.\n\nBaseline serum creatinine will be defined as the most recent stable outpatient serum creatinine measurement obtained within the",{"measure":18,"description":19,"timeFrame":20},"7-Day Intensive Care Unit Mortality","The number and proportion of participants who die in the intensive care unit within 7 days after ICU admission will be recorded. Deaths occurring after live discharge or transfer from the ICU will not be classified as ICU deaths.","Within 7 days after ICU admission",{"measure":22,"description":23,"timeFrame":24},"30-Day Intensive Care Unit Mortality","The number and proportion of participants who die in the intensive care unit within 30 days after ICU admission will be recorded. Deaths occurring after live discharge or transfer from the ICU will not be classified as ICU deaths.","Within 30 days after ICU admission",{"measure":26,"description":27,"timeFrame":28},"Intensive Care Unit-Free Days Through Day 30","The number of days alive and free from the intensive care unit (ICU) during the first 30 days after ICU admission will be calculated. Participants who die before day 30 will be assigned 0 ICU-free days. Participants who remain in the ICU through day 30 will also be assigned 0 ICU-free days. For participants discharged alive from the ICU before day 30, ICU-free days will be calculated as the number of days alive and outside the ICU through day 30. Any subsequent ICU readmission during this period will not be counted as ICU-free time. Higher values indicate a more favorable outcome.","From ICU admission through day 30",{"measure":30,"description":31,"timeFrame":28},"Ventilator-Free Days Through Day 30","Ventilator-free days will be defined as the number of days during the first 28 days after ICU admission that the participant is alive and free from invasive mechanical ventilation delivered through an endotracheal tube or tracheostomy. Participants who die before day 28 will be assigned 0 ventilator-free days. Participants who remain invasively mechanically ventilated through day 28 will also be assigned 0 ventilator-free days. For participants successfully liberated from invasive mechanical ventilation before day 28, ventilator-free days will be counted from successful liberation through day 28. If invasive mechanical ventilation is restarted, the intervening period will not be considered definitive ventilator-free time until final successful liberation. Participants who never receive invasive mechanical ventilation will have 28 ventilator-free days. Noninvasive ventilation and high-flow nasal oxygen will not be considered invasive mechanical ventilation for this outcome.",null,{"allocation":32,"interventionModel":32,"interventionModelDescription":32,"primaryPurpose":32,"observationalModel":34,"timePerspective":35,"maskingInfo":32},"COHORT","PROSPECTIVE","This single-center, prospective, noninterventional cohort study will evaluate the predictive performance of the Renal Angina Index (RAI) for subsequent development of moderate-to-severe acute kidney injury in critically ill adults. Consecutive eligible patients admitted to the participating adult intensive care unit will be screened for enrollment irrespective of admission source or subsequently calculated RAI category. Clinical management will remain entirely under the responsibility of the treating team, and no treatment or diagnostic intervention will be assigned by the study protocol.\n\nThe RAI will be calculated 24 hours after ICU admission. The clinical-risk component will be determined using the highest applicable prespecified risk category at ICU admission, and the renal-injury component will be determined from the absolute change in serum creatinine between ICU admission and 24 hours. The resulting RAI ranges from 1 to 40, with RAI ≥10 representing the prespecified high-risk threshold. RAI \\\u003C10 and RAI ≥10 will be evaluated as prespecified risk strata within a single observational cohort.\n\nThe primary outcome will be development of KDIGO stage 2 or stage 3 AKI during the 48 hours following RAI calculation. AKI severity will be classified using serum creatinine, urine-output, and acute renal replacement therapy criteria. Stage 2 AKI will be defined as serum creatinine 2.0-2.9 times baseline or urine output \\\u003C0.5 mL\u002Fkg\u002Fhour for at least 12 hours. Stage 3 AKI will be defined as serum creatinine ≥3.0 times baseline, an increase in serum creatinine to ≥4.0 mg\u002FdL in the setting of AKI, initiation of acute renal replacement therapy, urine output \\\u003C0.3 mL\u002Fkg\u002Fhour for at least 24 hours, or anuria for at least 12 hours. The highest KDIGO stage reached by any applicable criterion will determine AKI severity. KDIGO Baseline serum creatinine for AKI staging will be defined as the most recent stable outpatient serum creatinine measurement obtained within the 6 months preceding ICU admission. Participants without an eligible baseline serum creatinine measurement will be excluded, and no alternative baseline creatinine estimation or imputation will be performed. The baseline serum creatinine used for KDIGO staging will be distinct from the ICU-admission serum creatinine used to calculate the RAI renal-injury component.\n\nSerum creatinine measurements obtained during routine care at ICU admission and approximately 24, 48, and 72 hours after admission will be recorded. Urine output will be prospectively obtained from routine clinical documentation and evaluated according to KDIGO duration and weight-adjusted thresholds. Renal replacement therapy initiation and its indication will also be recorded. Participants who have already developed KDIGO stage 2 or stage 3 AKI at or before the 24-hour RAI assessment will not be included in the primary incident-AKI prediction analysis, because the target outcome will already have occurred before application of the index test.\n\nDiscrimination of the RAI for development of KDIGO stage 2-3 AKI will be evaluated using the area under the receiver operating characteristic curve with 95% confidence intervals. For the prespecified threshold of RAI ≥10, sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratios, and overall classification accuracy will be reported with 95% confidence intervals. An alternative threshold based on the Youden index will be considered exploratory.\n\nSecondary clinical outcomes will include 7-day and 30-day intensive care unit mortality, intensive care unit length of stay, and duration of invasive mechanical ventilation.","Adult patients admitted to the participating adult intensive care unit will be considered for enrollment. Consecutive admissions meeting the eligibility criteria will be screened regardless of admission source or subsequently calculated Renal Angina Index category. The Renal Angina Index will be calculated 24 hours after ICU admission using routinely collected clinical and laboratory data.",[39],{"label":40,"type":32,"description":41,"interventionNames":42},"Eligible Adult ICU Patients","A single prospective cohort of consecutive eligible adult patients admitted to the participating intensive care unit. The Renal Angina Index (RAI) will be calculated 24 hours after ICU admission using routinely collected clinical and laboratory data. Participants will subsequently be analyzed according to the prespecified RAI strata of \\\u003C10 and ≥10. No treatment assignment will be made by the study protocol.",[43],"Diagnostic Test: Renal Angina Index Assessment",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":32},"DIAGNOSTIC_TEST","Renal Angina Index Assessment","The Renal Angina Index will be calculated 24 hours after ICU admission using routinely available clinical and laboratory information. The RAI will be used as a prognostic index to evaluate the risk of subsequent KDIGO stage 2 or stage 3 acute kidney injury. No treatment, diagnostic procedure, or therapeutic intervention will be assigned on the basis of the RAI by the study protocol.",[40],[51,55],{"name":52,"affiliation":53,"role":54},"Senem Girgin, M.D.","Izmir Katip Celebi University Atatürk Training and Research Hospital","PRINCIPAL_INVESTIGATOR",{"name":56,"affiliation":53,"role":57},"Murat Aksun, M.D.","STUDY_DIRECTOR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":32,"email":63},"Dilara Dilan Fidan Menekşe, M.D.","CONTACT","+90 545 636 76 80","dln.fidan@hotmail.com",{"name":65,"role":61,"phone":66,"phoneExt":32,"email":67},"Ahmet Salih Tüzen, M.D.","+90 535 391 55 77","astuzen@icloud.com",[69],{"facility":70,"status":32,"city":71,"state":72,"zip":73,"country":74,"countryCode":32,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Izmir Katip Celebi University Ataturk Training and Research Hospital","Izmir","İzmir","35360","Turkey (Türkiye)",{"type":76,"coordinates":77},"Point",[78,79],27.13838,38.41273,{"lat":79,"lon":78},[82,85,86,87],{"name":56,"role":61,"phone":83,"phoneExt":32,"email":84},"+90 552 363 16 14","murataksun@yahoo.com",{"name":60,"role":61,"phone":62,"phoneExt":32,"email":63},{"name":52,"role":54,"phone":32,"phoneExt":32,"email":32},{"name":65,"role":88,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"type":54,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Ahmet Salih Tüzen, MD","Principal Investigator","100659268","renal-angina-index-for-predicting-acute-kidney-injury-in-adult-icu-patients-100659268",false,"NCT07863505","Renal Angina Index for Predicting Acute Kidney Injury in Adult ICU Patients","Predictive Performance of the Renal Angina Index for Acute Kidney Injury in Adult Intensive Care Unit Patients: A Prospective Cohort Study","Inclusion Criteria:\n\n* Age 18 years or older.\n* Admission to the participating adult intensive care unit.\n* Availability of serum creatinine measurements at ICU admission and 24 hours after ICU admission.\n* Availability of a stable outpatient serum creatinine measurement obtained within the 6 months preceding ICU admission that can be used as the baseline value for KDIGO acute kidney injury staging.\n* Availability of the clinical and laboratory data required to calculate the Renal Angina Index at 24 hours after ICU admission.\n* Availability of serum creatinine and urine-output data required for assessment of the primary outcome during the 48 hours following Renal Angina Index calculation.\n* Written informed consent from the participant or a legally authorized representative.\n\nExclusion Criteria:\n\n* Age younger than 18 years.\n* KDIGO stage 2 or stage 3 acute kidney injury present at ICU admission or developing before calculation of the Renal Angina Index at 24 hours after ICU admission.\n* Initiation of acute renal replacement therapy before calculation of the Renal Angina Index.\n* End-stage kidney disease requiring chronic renal replacement therapy.\n* History of kidney transplantation.\n* Absence of an eligible stable outpatient baseline serum creatinine measurement within the 6 months preceding ICU admission.\n* Death, discharge, or transfer from the ICU within the first 24 hours after admission, preventing calculation of the Renal Angina Index.\n* Insufficient data for assessment of the primary outcome during the 48-hour period following Renal Angina Index calculation.\n* Pregnancy.","ALL","18 Years",{"count":102,"type":103},324,"ESTIMATED","OBSERVATIONAL","Acute kidney injury (AKI) is a frequent complication of critical illness and is associated with increased morbidity and mortality. Early identification of patients at risk of progressing to moderate-to-severe AKI may facilitate closer monitoring and timely implementation of kidney-protective strategies.\n\nThis prospective observational cohort study will evaluate the predictive performance of the Renal Angina Index (RAI) for the development of Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 or stage 3 AKI in adult intensive care unit patients. Consecutive eligible patients admitted to the participating adult intensive care unit will be enrolled. The RAI will be calculated 24 hours after ICU admission using routinely available clinical characteristics and the change in serum creatinine between ICU admission and 24 hours.\n\nThe primary outcome will be the development of KDIGO stage 2 or stage 3 AKI during the subsequent 48 hours. AKI staging will incorporate serum creatinine, urine-output, and renal replacement therapy criteria according to KDIGO definitions. The predictive performance of RAI will be evaluated using receiver operating characteristic analysis and the prespecified RAI threshold of ≥10.\n\nSecondary outcomes will include 7-day and 30-day intensive care unit mortality, intensive care unit length of stay, and duration of invasive mechanical ventilation.",[107],"Acute Kidney Injury",[109,107,110,111,112,113],"Renal Angina Index","Intensive Care Unit","Critically Ill Adults","Kidney Injury Prediction","Risk Stratification","NOT_YET_RECRUITING","2026-10-02",{"date":117,"type":118},"2026-10-07","ACTUAL",{"date":120,"type":103},"2026-11-01",{"date":122,"type":103},"2027-11-30",{"name":5,"class":6},1]