Hemoglobin Levels and Resolution Time of Diabetic Ketoacidosis in Pediatric Patients

Aydin Adnan Menderes University

Status: Active, not recruiting

Conditions: Pediatrics; Diabete Type 1; Child; Ketoacidosis, Diabetic

Study type: Observational

Funder types: Other

Identifiers

NCT07377604

ADUPEDDKAHB2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

150 participants in 1 patient group

Pediatric Patients With Diabetic Ketoacidosis

Description:

Children and adolescents aged 1-18 years diagnosed with diabetic ketoacidosis (DKA) according to ISPAD criteria. All patients included in this cohort were managed according to standard institutional DKA treatment protocols. Hemoglobin levels were assessed after biochemical resolution of DKA, and patients were categorized analytically as anemic or non-anemic for outcome comparisons.