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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Predictive Performance of Admission Perfusion Index for Diabetic Ketoacidosis Severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Advanced chronic liver failure.
- •End-stage renal disease or dialysis treatment.
- •Inability to obtain the essential study variables or presence of missing data.
- •Refusal to participate in the study.
- •Repeat emergency department presentation by the same participant; only the first presentation will be included.
研究组 & 干预措施
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.
结局指标
主要结局
Predictive Performance of Admission Perfusion Index for Diabetic Ketoacidosis Severity
时间窗: 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.
次要结局
- Predictive Performance of the Lactate-to-Perfusion Index Ratio for Diabetic Ketoacidosis Severity(At emergency department admission (baseline))
- Predictive Performance of Admission Serum Lactate for Diabetic Ketoacidosis Severity(From emergency department admission until diabetic ketoacidosis resolution, assessed up to 7 days.)
- Time to Diabetic Ketoacidosis Resolution(From emergency department admission through hospital discharge or in-hospital death, assessed up to 30 days.)
- Intensive Care Unit Admission(From intensive care unit admission through intensive care unit discharge or in-hospital death, assessed up to 30 days.)
- Hospital Length of Stay(From hospital admission through hospital discharge or in-hospital death, assessed up to 30 days.)
- Intensive Care Unit Length of Stay(From intensive care unit admission through intensive care unit discharge or in-hospital death)
- Mechanical Ventilation Requirement Within the First 24 Hours(Within the first 24 hours after emergency department admission)
- Vasopressor Requirement Within the First 24 Hours(Within the first 24 hours after emergency department admission)
- In-Hospital Mortality(From emergency department admission through hospital discharge or in-hospital death, assessed up to 30 days.)
研究者
Tugba Sanalp Menekse
Associate Professor of Emergency Medicine
Ankara Etlik City Hospital