Adnan Menderes University
Aydin, Turkey (Türkiye)
NCT Number: NCT07377604
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 study is active but is not currently recruiting participants.
Notify Me1 year–18 year
All sexes
Observational
Aydin, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: From PICU admission until PICU discharge, assessed up to 30 days
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 hospital admission until hospital discharge, assessed up to 30 days
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.
Aydin Adnan Menderes University
Other
Impact of Anemia on Time to Resolution of Diabetic Ketoacidosis and Hospital Outcomes in Children: A Single-Center Retrospective Cohort Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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