Impact of Anemia on Time to Resolution of Diabetic Ketoacidosis and Hospital Outcomes in Children: A Single-Center Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Time to Resolution of Diabetic Ketoacidosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Pediatric Patients With Diabetic Ketoacidosis
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.
结局指标
主要结局
Time to Resolution of Diabetic Ketoacidosis
时间窗: 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.
次要结局
- Pediatric Intensive Care Unit (PICU) Length of Stay(From PICU admission until PICU discharge, assessed up to 30 days)
- Total Hospital Length of Stay(From hospital admission until hospital discharge, assessed up to 30 days)
研究者
Aykut Çağlar, MD
Associate Professor
Aydin Adnan Menderes University