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NCT Number: NCT07377604

Hemoglobin Levels and Resolution Time of Diabetic Ketoacidosis in Pediatric Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Time to Resolution of Diabetic Ketoacidosis

    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.

Secondary outcomes

  1. Pediatric Intensive Care Unit (PICU) Length of Stay

    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.

  2. Total Hospital Length of Stay

    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.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2025
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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