Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07377604
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.
Study:
NCT07377604
Study Brief:
Protocol Section:
NCT07377604