Perfusion Index for Predicting Diabetic Ketoacidosis Severity in the Emergency Department

NCT07820371 | Recruiting

• 1 other identifier: AESH-BADEK1-2026-674
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Ketoacidosis

Keywords

Perfusion Index; Peripheral Perfusion; Serum Lactate; Lactate-to-Perfusion Index Ratio; Diabetic Ketoacidosis Severity; Emergency Department

Outcome Measures

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.

  At emergency department admission (baseline)

Secondary Outcomes (9)

• 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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (2)

Ankara Etlik City Hospital, Department of Emergency Medicine

Ankara, Ankara, 06170, Turkey (Türkiye)

NOT YET RECRUITING

Ankara Etlik City Hospital, Department of Emergency Medicine

Ankara, Ankara, 06170, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetic Ketoacidosis; Emergencies

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tuğba Sanalp Menekşe

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuğba Sanalp Menekşe, MD

CONTACT

+90 551 414 6422; tugba.sanalp@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine

Study Record Dates

• First Submitted: September 5, 2026
• First Posted: September 15, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)