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CompletedNCT06327737Updated Mar 25, 2024

Diabetic Ketoacidosis Diagnosis and Management

An observational study in Metabolic Acidosis, Diabetic Ketoacidosis and Brain Edema, sponsored by Akdeniz University. Completed at 1 site in Turkey. Open to participants aged 15 Days to 18 Years. Per ClinicalTrials.gov, last updated 2024-03-25.

Primary conditionDiabetic KetoacidosisRegistry: AcidosisReclassifiedWhy we changed it
Registry
Acidosis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Diabetic Ketoacidosis
Why
  1. The study's listed conditions name Diabetic Ketoacidosis, a narrower term within Acidosis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Akdeniz University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
55
Ages
15 Days to 18 Years
Sex
All
01

Study summary

This is the first and only study conducted on the use of capnography in children diagnosed with DKA to evaluate the initial clinical grading of DKA, monitor clinical improvement, and predict complications such as brain edema.

Read the detailed description

Purpose: In this study, the contribution of this non-invasive follow-up method to the management of DKA and the reduction of the frequency of invasive procedures was investigated in patients diagnosed with diabetic ketoacidosis (DKA) in the pediatric emergency department and followed up with capnography

Method: This study is a prospective clinical study. Between October 2020- November 2022, EtCO2 and IPI follow-up of 0-18 year-old pediatric patients diagnosed with DKA in the Pediatric Emergency Service of Akdeniz University Medical Faculty Hospital was performed by capnography. DKA diagnosis, grading, clinical follow-up and treatment termination criteria of the patients were determined according to the ISPAD 2018 Diagnosis and Treatment Guidelines. In the study; During the clinical follow-up, changes in GCS, blood glucose, vital, blood gas and capnograph parameters were examined. Demographic data were analyzed in all patients and in groups of patients who underwent DKA grading. GCS, blood gas and capnograph parameters were compared in the patient groups with DKA grading. Diagnostic test performances of blood gas and capnograph parameters were compared to detect low GCS

02

Conditions studied

  • Metabolic Acidosis
  • Diabetic Ketoacidosis
  • Brain Edema

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Keywords

  • Type 1 diabetes mellitus (Type 1 DM)
  • Diabetic Ketoacidosis (DKA)
  • Capnography
  • Blood gas
  • Integrated Pulmonary Index
  • End tidal Carbon Dioxide (EtCO2)
03

In context

Diabetic Ketoacidosis Reclassified

76 studies on the registry are indexed under Diabetic Ketoacidosis; 17 are open to participants now.

This study's enrollment of 55 is below the median of 100 across 29 observational studies indexed under Diabetic Ketoacidosis.

Browse Diabetic Ketoacidosis studies →

Lead sponsor

Akdeniz University is the lead sponsor of 297 studies on the registry; 62 are open to participants now.

Compared within Diabetic Ketoacidosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acidosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
15 Days to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

During the study, 55 of 66 patients diagnosed with DKA in the pediatric emergency department of our hospital were included in the study. One of our patients was during the researcher's leave; 7 of them were excluded from the study because they were in periods when capnograph cannula was not available in our hospital and 3 of them were excluded due to patient non-compliance.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The study group consisted of pediatric patients aged 0-18 years who were diagnosed with Diabetic Ketoacidosis and applied to Akdeniz University pediatric emergency department.
  • Written consent was obtained.

Exclusion criteria

Exclusion Criteria:

  • Who did not give written consent were not included in the study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
55 participants (actual)
Target follow-up
2 Days
Patient registry
Yes

Interventions

  • Diagnostic testCapnography

    This is non-invasive follow-up method to the management of DKA and the reduction of the frequency of invasive procedures was investigated in patients diagnosed with diabetic ketoacidosis (DKA) in the pediatric emergency department and followed up with capnography.

06

What researchers measure

Primary outcomes

  1. Correlation between PCO2 and EtCO2

    The positive linear correlation between PCO2 and EtCO2 indicates that acidosis can be monitored with EtCO2.

    Time frame: 2 days

  2. Correlation between Integrated Pulmonary Index and degree of acidosis

    Detection of a positive linear correlation between those with Integrated Pulmonary Index \<8 and the degree of acidosis

    Time frame: 2 days

  3. Prediction of cerebral edema with Integrated Pulmonary Index

    Detection of significant decrease in Glasgow Coma Scale (GCS\<13) in patients with Integrated Pulmonary Index \<4

    Time frame: 2 days

07

Study locations

1 site
  • Akdeniz University
    Antalya, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06327737
Lead sponsor
Akdeniz University
Collaborators
Ceren Kahraman
Responsible party
Ozlem Tolu Kendir (Assoc. Prof., Akdeniz University) — Principal investigator
First posted
Mar 25, 2024
Start date
Dec 15, 2020
Primary completion
Nov 15, 2022
Completion
Mar 15, 2023
Last update
Mar 25, 2024

Study contacts

OZLEM TOLU KENDIR, Assoc. Prof.
principal investigator · Akdeniz University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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