[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656020":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":51,"studyPopulation":52,"armGroups":53,"interventions":47,"overallOfficials":57,"centralContacts":61,"locations":67,"responsibleParty":90,"collaborators":47,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":47,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":47,"enrollmentInfo":102,"targetDuration":47,"studyType":105,"phases":47,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":83,"whyStopped":47,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Ankara Etlik City Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"Predictive Performance of Admission Perfusion Index for Diabetic Ketoacidosis Severity","The ability of the perfusion index measured at emergency department admission to predict diabetic ketoacidosis severity will be evaluated. Severity will be classified as mild (pH 7.25-7.30 and\u002For serum bicarbonate 15-18 mmol\u002FL), moderate (pH 7.00-7.24 and\u002For serum bicarbonate 10-14.9 mmol\u002FL), or severe (pH below 7.00 and\u002For serum bicarbonate below 10 mmol\u002FL). Predictive performance will be assessed using receiver operating characteristic curve analysis, including the area under the curve and an optimal cutoff value determined using the Youden index.","At emergency department admission (baseline)",[14,17,21,25,29,33,37,41,44],{"measure":15,"description":16,"timeFrame":12},"Predictive Performance of the Lactate-to-Perfusion Index Ratio for Diabetic Ketoacidosis Severity","The lactate-to-perfusion index ratio will be calculated by dividing the serum lactate level in mmol\u002FL by the simultaneously measured perfusion index percentage. Its ability to discriminate diabetic ketoacidosis severity will be evaluated using receiver operating characteristic curve analysis, including the area under the curve and an optimal cutoff value determined using the Youden index.",{"measure":18,"description":19,"timeFrame":20},"Predictive Performance of Admission Serum Lactate for Diabetic Ketoacidosis Severity","The ability of the serum lactate level measured at emergency department admission as part of routine clinical care to predict diabetic ketoacidosis severity will be evaluated using receiver operating characteristic curve analysis, including the area under the curve and an optimal cutoff value determined using the Youden index.","From emergency department admission until diabetic ketoacidosis resolution, assessed up to 7 days.",{"measure":22,"description":23,"timeFrame":24},"Time to Diabetic Ketoacidosis Resolution","Time in hours from emergency department admission until all predefined diabetic ketoacidosis resolution criteria are met: blood glucose below 200 mg\u002FdL, serum bicarbonate at least 15 mmol\u002FL, venous pH above 7.30, and closure of the anion gap and\u002For resolution of ketosis.","From emergency department admission through hospital discharge or in-hospital death, assessed up to 30 days.",{"measure":26,"description":27,"timeFrame":28},"Intensive Care Unit Admission","The number and percentage of participants admitted to the intensive care unit during hospitalization will be recorded.","From intensive care unit admission through intensive care unit discharge or in-hospital death, assessed up to 30 days.",{"measure":30,"description":31,"timeFrame":32},"Hospital Length of Stay","The total duration of hospitalization will be recorded in days from hospital admission to hospital discharge or in-hospital death.","From hospital admission through hospital discharge or in-hospital death, assessed up to 30 days.",{"measure":34,"description":35,"timeFrame":36},"Intensive Care Unit Length of Stay","Among participants admitted to the intensive care unit, the total duration of intensive care unit stay will be recorded in days.","From intensive care unit admission through intensive care unit discharge or in-hospital death",{"measure":38,"description":39,"timeFrame":40},"Mechanical Ventilation Requirement Within the First 24 Hours","The number and percentage of participants requiring mechanical ventilation within the first 24 hours after emergency department admission will be recorded.","Within the first 24 hours after emergency department admission",{"measure":42,"description":43,"timeFrame":40},"Vasopressor Requirement Within the First 24 Hours","The number and percentage of participants requiring vasopressor treatment within the first 24 hours after emergency department admission will be recorded.",{"measure":45,"description":46,"timeFrame":24},"In-Hospital Mortality","The number and percentage of participants who die during hospitalization will be recorded.",null,{"allocation":47,"interventionModel":47,"interventionModelDescription":47,"primaryPurpose":47,"observationalModel":49,"timePerspective":50,"maskingInfo":47},"COHORT","PROSPECTIVE","This is a prospective, single-center observational cohort study of adults diagnosed with diabetic ketoacidosis in the emergency department. The primary objective is to evaluate the association between the perfusion index measured at admission and diabetic ketoacidosis severity.\n\nDiabetic ketoacidosis severity will be classified as mild, moderate, or severe according to admission pH and serum bicarbonate levels. The admission perfusion index will be measured, when possible, after the patient has rested for at least five minutes, under conditions without movement or marked external light interference. Three consecutive perfusion index measurements will be obtained at each measurement time, and their median will be used in the analyses. The admission perfusion index measurement and serum lactate sampling will be performed within the same time period and, whenever possible, before intravenous fluid and insulin treatment is initiated. A further perfusion index measurement will be recorded at the fourth hour of treatment.\n\nSerum lactate values obtained as part of routine clinical care will be recorded. The lactate-to-perfusion index ratio will be calculated as serum lactate in mmol\u002FL divided by the perfusion index percentage. The predictive performances of the perfusion index, serum lactate, and the lactate-to-perfusion index ratio for diabetic ketoacidosis severity will be evaluated and compared.\n\nSecondary outcomes will include time to diabetic ketoacidosis resolution, intensive care unit admission, hospital length of stay, intensive care unit length of stay, mechanical ventilation within the first 24 hours, vasopressor use within the first 24 hours, and in-hospital mortality. The investigators will not assign any diagnostic or therapeutic intervention, and patient management will follow routine clinical practice.","The study population will consist of adults aged 18 years or older who present to the Adult Emergency Department of Ankara Etlik City Hospital, are diagnosed with diabetic ketoacidosis, meet all eligibility criteria, and provide written informed consent. Only the first eligible presentation of each participant will be included.",[54],{"label":55,"type":47,"description":56,"interventionNames":47},"Adults With Diabetic Ketoacidosis","Adults aged 18 years or older who are diagnosed with diabetic ketoacidosis in the emergency department and meet the study eligibility criteria. Perfusion index measurements and routinely obtained serum lactate values will be recorded, and participants will be followed for clinical outcomes during hospitalization.",[58],{"name":59,"affiliation":5,"role":60},"Tuğba Sanalp Menekşe","PRINCIPAL_INVESTIGATOR",[62],{"name":63,"role":64,"phone":65,"phoneExt":47,"email":66},"Tuğba Sanalp Menekşe, MD","CONTACT","+90 551 414 6422","tugba.sanalp@hotmail.com",[68,82],{"facility":69,"status":70,"city":71,"state":71,"zip":72,"country":73,"countryCode":47,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Ankara Etlik City Hospital, Department of Emergency Medicine","NOT_YET_RECRUITING","Ankara","06170","Turkey (Türkiye)",{"type":75,"coordinates":76},"Point",[77,78],32.85427,39.91987,{"lat":78,"lon":77},[81],{"name":63,"role":64,"phone":65,"phoneExt":47,"email":66},{"facility":69,"status":83,"city":71,"state":71,"zip":72,"country":73,"countryCode":47,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"RECRUITING",{"type":75,"coordinates":85},[77,78],{"lat":78,"lon":77},[88],{"name":59,"role":64,"phone":89,"phoneExt":47,"email":66},"+9 0551 414 64 22",{"type":60,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Tugba Sanalp Menekse","Associate Professor of Emergency Medicine","100656020","perfusion-index-for-predicting-diabetic-ketoacidosis-severity-in-the-emergency-department-100656020",false,"NCT07820371","Perfusion Index for Predicting Diabetic Ketoacidosis Severity in the Emergency Department","Value of the Perfusion Index in Predicting the Severity of Diabetic Ketoacidosis in the Emergency Department and Evaluation of Its Combination With Lactate: A Prospective Cohort Study","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Diagnosis of diabetic ketoacidosis in the emergency department.\n3. Ability to obtain perfusion index and serum lactate measurements during the initial assessment after admission.\n4. Provision of written informed consent by the patient or, when necessary, the patient's legally authorized representative.\n\nExclusion Criteria:\n\n1. Pregnancy.\n2. Trauma, major bleeding, or hemorrhagic shock.\n3. Cardiac arrest.\n4. Conditions that may prevent reliable perfusion index measurement, including advanced hypothermia, severe peripheral arterial disease, or amputation, burns, severe edema, or deformity at the measurement site.\n5. Advanced chronic liver failure.\n6. End-stage renal disease or dialysis treatment.\n7. Inability to obtain the essential study variables or presence of missing data.\n8. Refusal to participate in the study.\n9. Repeat emergency department presentation by the same participant; only the first presentation will be included.","ALL","18 Years",{"count":103,"type":104},140,"ESTIMATED","OBSERVATIONAL","This prospective observational cohort study will evaluate whether the perfusion index measured at emergency department admission is associated with the severity of diabetic ketoacidosis in adults. The study will include 140 patients aged 18 years or older who are diagnosed with diabetic ketoacidosis in the emergency department.\n\nThe perfusion index will be measured using pulse oximetry. Serum lactate measured as part of routine clinical care will also be recorded, and the lactate-to-perfusion index ratio will be calculated. The ability of the perfusion index, serum lactate, and the lactate-to-perfusion index ratio to predict diabetic ketoacidosis severity will be compared. Their associations with time to diabetic ketoacidosis resolution, intensive care unit admission, hospital and intensive care unit length of stay, mechanical ventilation, vasopressor use, and in-hospital mortality will also be evaluated. No treatment will be assigned by the investigators, and all patients will receive routine clinical care.",[108],"Diabetic Ketoacidosis",[110,111,112,113,114,115],"Perfusion Index","Peripheral Perfusion","Serum Lactate","Lactate-to-Perfusion Index Ratio","Diabetic Ketoacidosis Severity","Emergency Department","2026-09-14",{"date":118,"type":119},"2026-09-16","ACTUAL",{"date":121,"type":119},"2026-09-15",{"date":123,"type":104},"2027-04-30",{"name":5,"class":6},2]