Diabetic Ketoacidosis
Conditions
Keywords
Perfusion Index, Peripheral Perfusion, Serum Lactate, Lactate-to-Perfusion Index Ratio, Diabetic Ketoacidosis Severity, Emergency Department
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Ankara Etlik City Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older. 2. Diagnosis of diabetic ketoacidosis in the emergency department. 3. Ability to obtain perfusion index and serum lactate measurements during the initial assessment after admission. 4. Provision of written informed consent by the patient or, when necessary, the patient's legally authorized representative.
Exclusion criteria
1. Pregnancy. 2. Trauma, major bleeding, or hemorrhagic shock. 3. Cardiac arrest. 4. 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. 5. Advanced chronic liver failure. 6. End-stage renal disease or dialysis treatment. 7. Inability to obtain the essential study variables or presence of missing data. 8. Refusal to participate in the study. 9. Repeat emergency department presentation by the same participant; only the first presentation will be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive Performance of Admission Perfusion Index for Diabetic Ketoacidosis Severity | At emergency department admission (baseline) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictive Performance of the Lactate-to-Perfusion Index Ratio for Diabetic Ketoacidosis Severity | At emergency department admission (baseline) | 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. |
| Predictive Performance of Admission Serum Lactate for Diabetic Ketoacidosis Severity | From emergency department admission until diabetic ketoacidosis resolution, assessed up to 7 days. | 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 to Diabetic Ketoacidosis Resolution | From emergency department admission through hospital discharge or in-hospital death, assessed up to 30 days. | 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. |
| Intensive Care Unit Admission | From intensive care unit admission through intensive care unit discharge or in-hospital death, assessed up to 30 days. | The number and percentage of participants admitted to the intensive care unit during hospitalization will be recorded. |
| Hospital Length of Stay | From hospital admission through hospital discharge or in-hospital death, assessed up to 30 days. | The total duration of hospitalization will be recorded in days from hospital admission to hospital discharge or in-hospital death. |
| Intensive Care Unit Length of Stay | From intensive care unit admission through intensive care unit discharge or in-hospital death | Among participants admitted to the intensive care unit, the total duration of intensive care unit stay will be recorded in days. |
| Mechanical Ventilation Requirement Within the First 24 Hours | Within the first 24 hours after emergency department admission | The number and percentage of participants requiring mechanical ventilation within the first 24 hours after emergency department admission will be recorded. |
| Vasopressor Requirement Within the First 24 Hours | Within the first 24 hours after emergency department admission | The number and percentage of participants requiring vasopressor treatment within the first 24 hours after emergency department admission will be recorded. |
| In-Hospital Mortality | From emergency department admission through hospital discharge or in-hospital death, assessed up to 30 days. | The number and percentage of participants who die during hospitalization will be recorded. |
Countries
Turkey (Türkiye)
Contacts
CONTACTTuğba Sanalp Menekşe, MD
PRINCIPAL_INVESTIGATORTuğba Sanalp Menekşe
Ankara Etlik City Hospital
Outcome results
None listed