Perfusion index in the emergency department to gauge DKA severity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center observational cohort study enrolling adults with diabetic ketoacidosis to see if the ED perfusion index, measured after a brief rest, correlates with DKA severity. Three consecutive measurements will be used to generate a median value, and the lactate-to-perfusion index ratio will be calculated from routine lactate data. The study will compare the predictive performance of perfusion index, lactate, and their ratio for DKA severity and key clinical outcomes such as time to resolution, ICU admission, length of stay, mechanical ventilation, vasopressor use, and in-hospital mortality. No treatment will be assigned; data are collected from standard clinical care with consent. A second perfusion index measurement is also recorded at four hours after treatment initiation when feasible.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ankara Etlik City Hospital, Department of Emergency Medicine
  Ankara, Ankara, Turkey (Türkiye) Recruiting
• Ankara Etlik City Hospital, Department of Emergency Medicine
  Ankara, Ankara, Turkey (Türkiye) Not yet recruiting

Study contacts

• Principal investigator: Tuğba Sanalp Menekşe — Ankara Etlik City Hospital
• Study coordinator: Tuğba Sanalp Menekşe, MD
• Email: tugba.sanalp@hotmail.com
• Phone: +90 551 414 6422

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.