Hemoglobin Levels and Resolution Time of Diabetic Ketoacidosis in Pediatric Patients

N/AActive Not RecruitingNCT07377604

Aydin Adnan Menderes University150 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Diabete Type 1 Ketoacidosis, Diabetic Pediatrics Child

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Time to Resolution of Diabetic Ketoacidosis

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.

Time frame: From initiation of DKA treatment until biochemical resolution, assessed up to 7 days

Secondary Outcomes

Pediatric Intensive Care Unit (PICU) Length of Stay

Length 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.

Time frame: From PICU admission until PICU discharge, assessed up to 30 days

Total Hospital Length of Stay

Total 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.

Time frame: From hospital admission until hospital discharge, assessed up to 30 days