Perfusion Index for Predicting Diabetic Ketoacidosis Severity in the Emergency Department
ConditionDiabetic Ketoacidosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnkara Etlik City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Diagnosis of diabetic ketoacidosis in the emergency department.
Ability to obtain perfusion index and serum lactate measurements during the initial assessment after admission.
Provision of written informed consent by the patient or, when necessary, the patient's legally authorized representative.
Disqualifiers
Pregnancy.
Trauma, major bleeding, or hemorrhagic shock.
Cardiac arrest.
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
140 Participants
are grouped into 1 trial groupGroup A: Adults With Diabetic Ketoacidosis
Trial outcomes
Primary outcomes
1
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/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)Secondary outcomes
1
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)2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov