Diabetic KetoacidosisNCT07820371
Perfusion Index for Predicting Diabetic Ketoacidosis Severity in the Emergency Department
An observational study of Diabetic Ketoacidosis, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Ketoacidosis
- How many people
- 140 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Sep 2026to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Ankara Etlik City Hospital, Department of Emergency Medicine
Ankara, Ankara, 06170
Tuğba Sanalp Menekşe, MD, +90 551 414 6422, tugba.sanalp@hotmail.com
- Recruiting
Ankara Etlik City Hospital, Department of Emergency Medicine
Ankara, Ankara, 06170
Tuğba Sanalp Menekşe, +9 0551 414 64 22, tugba.sanalp@hotmail.com
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Diabetic Ketoacidosis
- Keywords
- Perfusion Index, Peripheral Perfusion, Serum Lactate, Lactate-to-Perfusion Index Ratio, Diabetic Ketoacidosis Severity, Emergency Department
- Medical subject headings
- Diabetic Ketoacidosis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At emergency department admission (baseline)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From emergency department admission through hospital discharge or in-hospital death, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start15 Sep 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tugba Sanalp Menekse, Ankara Etlik City Hospital
- Investigators
- Tuğba Sanalp Menekşe, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820371
- Sponsor's protocol ID
- AESH-BADEK1-2026-674
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07820371
- Acronym / sponsor ID
- AESH-BADEK1-2026-674
- Conditions
- Diabetic Ketoacidosis
- Keywords
- Perfusion Index, Peripheral Perfusion, Serum Lactate, Lactate-to-Perfusion Index Ratio, Diabetic Ketoacidosis Severity, Emergency Department
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive Performance of Admission Perfusion Index for Diabetic Ketoacidosis Severity
Time frame: 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.
9 secondary outcomes
Predictive Performance of the Lactate-to-Perfusion Index Ratio for Diabetic Ketoacidosis Severity
Time frame: At emergency department admission (baseline)
Predictive Performance of Admission Serum Lactate for Diabetic Ketoacidosis Severity
Time frame: From emergency department admission until diabetic ketoacidosis resolution, assessed up to 7 days.
Time to Diabetic Ketoacidosis Resolution
Time frame: From emergency department admission through hospital discharge or in-hospital death, assessed up to 30 days.
Intensive Care Unit Admission
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
Time frame: From hospital admission through hospital discharge or in-hospital death, assessed up to 30 days.
Intensive Care Unit Length of Stay
Time frame: From intensive care unit admission through intensive care unit discharge or in-hospital death
Mechanical Ventilation Requirement Within the First 24 Hours
Time frame: Within the first 24 hours after emergency department admission
Vasopressor Requirement Within the First 24 Hours
Time frame: Within the first 24 hours after emergency department admission
In-Hospital Mortality
Time frame: From emergency department admission through hospital discharge or in-hospital death, assessed up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tuğba Sanalp Menekşe principal investigator
Ankara Etlik City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Ketoacidosis, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğba Sanalp Menekşe, MD (+90 551 414 6422, tugba.sanalp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Performance of Admission Perfusion Index for Diabetic Ketoacidosis Severity (time frame: At emergency department admission (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.