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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From initiation of DKA treatment until biochemical resolution, assessed up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From PICU admission until PICU discharge, assessed up to 30 days |
| Total Hospital Length of Stay |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients treated for DKA in the pediatric emergency department and pediatric intensive care unit of a tertiary university hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adnan Menderes University | Aydin | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Małachowska, B., Michałek, D., Koptas, M., Pietras, W., Młynarski, W., Szadkowska, A., & Fendler, W. (2020). Changes in hematological parameters during first days of diabetic ketoacidosis treatment in children with type 1 diabetes mellitus. Clinical Diabetology, 9(3), 149-160. https://doi.org/10.5603/DK.2020.0006 | ||
| Background | Safinaz AE, Asmaa AS,Nouran Y,Rasha AT. Iron Deficiency Anemia in Children and Adolescents with Type I Diabetes, Is it a Real Problem?. The Medical Journal of Cairo University. 2021 Sep 89; 1603-19. | ||
| 36844374 | Background | Forestell B, Battaglia F, Sharif S, Eltorki M, Samaan MC, Choong K, Rochwerg B. Insulin Infusion Dosing in Pediatric Diabetic Ketoacidosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Crit Care Explor. 2023 Feb 17;5(2):e0857. doi: 10.1097/CCE.0000000000000857. eCollection 2023 Feb. | |
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De-identified individual participant data will not be shared publicly due to institutional policies, ethical restrictions, and the retrospective nature of the study using routinely collected clinical data. Aggregate data and statistical code may be provided upon reasonable request, subject to institutional approval.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2026 | Jan 22, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016883 | Diabetic Ketoacidosis |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D007662 | Ketosis |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
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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. |
| From hospital admission until hospital discharge, assessed up to 30 days |
| Background |
| Getawa S, Adane T. Hematological abnormalities among adults with type 1 diabetes mellitus at the University of Gondar Comprehensive Specialized Hospital. SAGE Open Med. 2022 Apr 24;10:20503121221094212. doi: 10.1177/20503121221094212. eCollection 2022. |
| 37568965 | Background | Kostopoulou E, Sinopidis X, Fouzas S, Gkentzi D, Dassios T, Roupakias S, Dimitriou G. Diabetic Ketoacidosis in Children and Adolescents; Diagnostic and Therapeutic Pitfalls. Diagnostics (Basel). 2023 Aug 4;13(15):2602. doi: 10.3390/diagnostics13152602. |
| 38326724 | Background | Faghir-Ganji M, Abdolmohammadi N, Nikbina M, Amanollahi A, Ansari-Moghaddam A, Rozhan R, Baradaran H. Prevalence of Anemia in Patients with Diabetes Mellitus: A Systematic Review and Meta-Analysis. Biomed Environ Sci. 2024 Jan 20;37(1):96-107. doi: 10.3967/bes2024.008. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |