Hemoglobin Levels and Resolution Time of Diabetic Ketoacidosis in Pediatric Patients

January 22, 2026 updated by: Aykut Çağlar, MD, Aydin Adnan Menderes University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From initiation of DKA treatment until biochemical resolution, assessed up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From PICU admission until PICU discharge, assessed up to 30 days
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.
From hospital admission until hospital discharge, assessed up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2013

Primary Completion (Actual)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADUPEDDKAHB2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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