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. The 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.
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. Diabetic 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. Serum 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/L 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. Secondary 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.
Study Type
OBSERVATIONAL
Enrollment
140
Ankara Etlik City Hospital, Department of Emergency Medicine
Ankara, Ankara, Turkey (Türkiye)
NOT_YET_RECRUITINGAnkara Etlik City Hospital, Department of Emergency Medicine
Ankara, Ankara, Turkey (Türkiye)
RECRUITINGPredictive 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/or serum bicarbonate 15-18 mmol/L), moderate (pH 7.00-7.24 and/or serum bicarbonate 10-14.9 mmol/L), or severe (pH below 7.00 and/or serum bicarbonate below 10 mmol/L). 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.
Time frame: At emergency department admission (baseline)
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/L 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.
Time frame: At emergency department admission (baseline)
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.
Time frame: From emergency department admission until diabetic ketoacidosis resolution, assessed up to 7 days.
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/dL, serum bicarbonate at least 15 mmol/L, venous pH above 7.30, and closure of the anion gap and/or resolution of ketosis.
Time frame: From emergency department admission through hospital discharge or in-hospital death, assessed up to 30 days.
Intensive Care Unit Admission
The number and percentage of participants admitted to the intensive care unit during hospitalization will be recorded.
Time frame: From intensive care unit admission through intensive care unit discharge or in-hospital death, assessed up to 30 days.
Hospital Length of Stay
The total duration of hospitalization will be recorded in days from hospital admission to hospital discharge or in-hospital death.
Time frame: From hospital admission through hospital discharge or in-hospital death, assessed up to 30 days.
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.
Time frame: From intensive care unit admission through intensive care unit discharge or in-hospital death
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.
Time frame: Within the first 24 hours after emergency department admission
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.
Time frame: Within the first 24 hours after emergency department admission
In-Hospital Mortality
The number and percentage of participants who die during hospitalization will be recorded.
Time frame: From emergency department admission through hospital discharge or in-hospital death, assessed up to 30 days.
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