Impact of Clinical Nursing Guideline on Outcomes of Children With Diabetic Ketoacidosis. (PED-DKA)

March 9, 2026 updated by: Khaleed Mohammed Shaikhah, Hawler Medical University

Impact of an Evidence-Based Practice Nursing Guideline on Clinical Outcomes in Children With Diabetic Ketoacidosis: A Quasi-Experimental Study

Diabetic ketoacidosis (DKA) is a serious and potentially life-threatening complication of diabetes mellitus in children and requires timely and structured management to prevent morbidity and mortality. Inconsistency in clinical practice and delayed recognition of complications may negatively affect patient outcomes. Evidence-based clinical nursing guidelines can improve the quality and consistency of care provided to children with DKA.

This study aimed to assess the impact of an evidence-based nursing guideline on clinical outcomes among children diagnosed with diabetic ketoacidosis. A quasi-experimental study design was used, including two groups: a control group receiving routine hospital care and an intervention group receiving care based on an evidence-based nursing guideline.

The guideline included structured nursing assessment, continuous monitoring of vital signs and neurological status, blood glucose monitoring, fluid balance monitoring, and early detection and management of complications. Clinical outcomes including blood glucose level, blood pH, neurological status, and duration of hospital stay were compared between the control and intervention groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetic ketoacidosis is one of the most common acute complications of diabetes mellitus in pediatric patients and remains a major cause of morbidity and hospital admission among children with diabetes. Effective management requires careful monitoring of metabolic status, fluid therapy, insulin administration, and early detection of complications such as cerebral edema and electrolyte imbalance.

Evidence-based nursing practice plays an essential role in improving the quality of care and patient safety during the management of pediatric diabetic ketoacidosis. Implementation of standardized clinical nursing guidelines can enhance clinical decision-making, improve monitoring of patients, and promote early identification of complications.

This study was conducted to assess the effectiveness of implementing an evidence-based clinical nursing guideline on clinical outcomes among children diagnosed with diabetic ketoacidosis. A quasi-experimental study design was used. Children admitted with diabetic ketoacidosis were divided into a control group receiving routine hospital management and an intervention group receiving care according to an evidence-based nursing guideline.

The guideline included structured monitoring of vital signs, neurological assessment using the Glasgow Coma Scale, frequent blood glucose monitoring, fluid balance monitoring, electrolyte monitoring, and nursing interventions aimed at early detection and prevention of complications.

Clinical outcomes evaluated in this study included blood glucose level, blood pH level, neurological status, and length of hospital stay. The findings of this study are expected to provide evidence regarding the effectiveness of structured nursing guidelines in improving the management and clinical outcomes of pediatric patients with diabetic ketoacidosis.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • Iraq
    • Kurdistan Region
      • Erbil, Kurdistan Region, Iraq, 44001
        • Raparin Pediatric Teaching Hospital

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children age from 6-16 years old.
  • Both sexes.
  • Have not other critical medical condition that interfere with study.
  • Diagnosed with diabetic ketoacidosis.
  • Have the ability to participate and accept to participate in the study.

Exclusion Criteria:

  • Children with comorbid chronic illnesses like congenital heart disease, renal failure, etc.
  • Recurrent admission during the same study period (only first admission considered).

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Children with diabetic ketoacidosis who received routine hospital management according to standard hospital protocol without implementation of the evidence-based nursing guideline.
Other: Intervention Group
Children with diabetic ketoacidosis who received care according to an evidence-based clinical nursing guideline including structured monitoring of vital signs, neurological assessment, blood glucose monitoring, fluid balance monitoring, and early detection and management of complications.
Other: Evidence-Based Nursing Guideline for Children with Diabetic Ketoacidosos
Implementation of an evidence-based clinical nursing guideline for the management of children with diabetic ketoacidosis. The guideline includes structured nursing assessment, continuous monitoring of vital signs and neurological status using the Glasgow Coma Scale, frequent blood glucose monitoring, fluid balance monitoring, electrolyte monitoring, and nursing interventions aimed at early detection and management of complications during DKA treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution Time of Diabetic ketoacidosis
Time Frame: From the time of hospital admission until normalization of metabolic parameters indicating resolution of diabetic ketoacidosis, assessed up to 48 hours.
Time required for resolution of diabetic ketoacidosis measured from hospital admission until normalization of metabolic parameters including blood glucose level, blood pH, and serum bicarbonate according to standard pediatric DKA management criteria.
From the time of hospital admission until normalization of metabolic parameters indicating resolution of diabetic ketoacidosis, assessed up to 48 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose level
Time Frame: From hospital admission to 48 hours after initiation of treatment
Change in blood glucose level during treatment of DKA, unitl return to normal standard level.
From hospital admission to 48 hours after initiation of treatment
Length of hospital stay
Time Frame: From hospital admission until hospital discharge, with follow-up assessment conducted up to 2 months after discharge
Total duration of hospital stay measured in days from admission until discharge of child to home.
From hospital admission until hospital discharge, with follow-up assessment conducted up to 2 months after discharge

Collaborators and Investigators

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

Sponsor

Hawler Medical University

Investigators

  • Principal Investigator: Khaleed M Shaikhah, MSc, Hawler Medical University/ College of Nursing

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

  • Wright, N., & Thomas, R. (2021). BSPED guideline: what we know and why the guideline was changed. Archives of Disease in Childhood-Education and Practice, 106(4), 226-228.

Helpful Links

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)

May 14, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

February 1, 2026

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED-DKA-GUIDELINE-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

ndividual participant data collected during the study will not be publicly shared due to institutional policies and ethical considerations related to patient confidentiality. Aggregated results will be reported in publications and academic reports.

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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