Ireland
--:--IST
Active, not recruiting Observational

Hemoglobin Levels and Resolution Time of Diabetic Ketoacidosis in Pediatric Patients

NCT07377604 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2013-11-11
Last updated
2026-01-30

Condition(s) studied

Diabete Type 1Ketoacidosis, DiabeticPediatricsChild

Study summary

This retrospective observational cohort study aims to evaluate the association between hemoglobin levels and the time to resolution of diabetic ketoacidosis (DKA) in pediatric patients. The primary hypothesis is that children with anemia experience a longer duration of DKA and prolonged hospitalization compared with non-anemic children. All eligible patients aged 1-18 years who were diagnosed with DKA between 01.01.2013 and 01.01.2025 at a tertiary pediatric center will be included. Clinical, laboratory, and treatment data will be collected from electronic medical records.

Eligibility

Sex
ALL
Min age
1 Year
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 1 and 18 years * Diagnosis of diabetic ketoacidosis (DKA) according to ISPAD criteria * First documented episode of DKA * Availability of hemoglobin measurement obtained within 0-24 hours after biochemical resolution of DKA * Availability of documented timestamps for initiation of DKA treatment and biochemical resolution Exclusion Criteria: * Hyperosmolar hyperglycemic state (HHS) or mixed DKA-HHS presentation * Known hemoglobinopathies (e.g., thalassemia major, sickle cell disease) * Evidence of active hemolysis documented in medical records (e.g., elevated lactate dehydrogenase, indirect hyperbilirubinemia, or low haptoglobin) * Red blood cell transfusion administered before or during the DKA treatment period * Missing hemoglobin measurement within the predefined post-resolution window (0-24 hours)

Primary outcome measure(s)

  • Time to Resolution of Diabetic Ketoacidosis — From initiation of DKA treatment until biochemical resolution, assessed up to 7 days
    Time from initiation of DKA treatment to biochemical resolution of DKA. Biochemical resolution is defined as achievement of a venous pH ≥ 7.30 and a serum bicarbonate level ≥ 15 mmol/L. The outcome is measured in hours and analyzed in relation to hemoglobin levels measured within 0-24 hours after DKA resolution.

Trial sites (1)

FacilityCityRegionStatus
Adnan Menderes University Aydin Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07377604 on ClinicalTrials.gov ↗ ← All trials in Turkey