An observational study in Diabetic Ketoacidosis, sponsored by Ankara Etlik City Hospital. Recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Ankara Etlik City Hospital · 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.
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.
76 studies on the registry are indexed under Diabetic Ketoacidosis; 17 are open to participants now.
This study's planned enrollment of 140 is above the median of 100 across 29 observational studies indexed under Diabetic Ketoacidosis.
Browse Diabetic Ketoacidosis studies →Ankara Etlik City Hospital is the lead sponsor of 176 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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)
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.
Plan to share: No — Individual participant data will not be shared. De-identified study data will be accessible only to the study investigators and will not be made available to third parties.
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Mar 2027, 6 months after the start.
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