Hemoglobin Levels and Resolution Time of Diabetic Ketoacidosis in Pediatric Patients

NCT07377604 | Active Not Recruiting

• 1 other identifier: ADUPEDDKAHB2025
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabete Type 1; Ketoacidosis, Diabetic; Pediatrics; Child

Keywords

Anemia; Ketoacidosis, Diabetic; Child; Hemoglobin; pediatric emergency

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients treated for DKA in the pediatric emergency department and pediatric intensive care unit of a tertiary university hospital.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University

Aydin, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  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.

  PMID: 36844374 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.

  PMID: 35492887 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.

  PMID: 37568965 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.

  PMID: 38326724 BACKGROUND

MeSH Terms

Conditions

Diabetic Ketoacidosis; Anemia

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 30, 2026
• Study Start: November 11, 2013
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)