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Hemoglobin Levels and Resolution Time of Diabetic Ketoacidosis in Pediatric Patients

Impact of Anemia on Time to Resolution of Diabetic Ketoacidosis and Hospital Outcomes in Children: A Single-Center Retrospective Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07377604
Enrollment
150
Registered
2026-01-30
Start date
2013-11-11
Completion date
2026-12-01
Last updated
2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child, Diabete Type 1, Ketoacidosis, Diabetic, Pediatrics

Keywords

Anemia, Ketoacidosis, Diabetic, Child, Hemoglobin, pediatric emergency

Brief 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.

Detailed description

This retrospective observational study investigates whether hemoglobin (Hb) levels, measured within 0-24 hours after biochemical resolution of diabetic ketoacidosis (DKA), are associated with the time to DKA resolution in pediatric patients. DKA resolution is defined as achievement of a venous pH ≥ 7.30 and a serum bicarbonate level ≥ 15 mmol/L. Only the first documented DKA episode for each patient will be included in the analysis. Secondary outcomes include pediatric intensive care unit (PICU) length of stay, total hospital length of stay, and DKA-related complications such as hypoglycemia, electrolyte disturbances, and suspected cerebral edema. Exploratory analyses will assess the association of pre-DKA hemoglobin levels (when available), hemoglobin levels at hospital discharge, and dehydration severity-reflected by admission hematocrit-with clinical outcomes.

Interventions

None listed

Sponsors

Aydin Adnan Menderes University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 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)

Design outcomes

Primary

MeasureTime frameDescription
Time to Resolution of Diabetic KetoacidosisFrom initiation of DKA treatment until biochemical resolution, assessed up to 7 daysTime 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.

Secondary

MeasureTime frameDescription
Pediatric Intensive Care Unit (PICU) Length of StayFrom PICU admission until PICU discharge, assessed up to 30 daysLength of stay in the pediatric intensive care unit measured from PICU admission to PICU discharge. The association with post-resolution hemoglobin levels will be evaluated.
Total Hospital Length of StayFrom hospital admission until hospital discharge, assessed up to 30 daysTotal length of hospital stay measured from hospital admission to hospital discharge. The association between hospital length of stay and post-resolution hemoglobin levels will be evaluated.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026