Impact of Clinical Nursing Guideline on Outcomes of Children With Diabetic Ketoacidosis.
PED-DKA
Impact of an Evidence-Based Practice Nursing Guideline on Clinical Outcomes in Children With Diabetic Ketoacidosis: A Quasi-Experimental Study
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedFirst Submitted
Initial submission to the registry
March 5, 2026
CompletedFirst Posted
Study publicly available on registry
March 12, 2026
CompletedMarch 12, 2026
March 1, 2026
7 months
March 5, 2026
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resolution Time of Diabetic ketoacidosis
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 Outcomes (2)
Blood glucose level
From hospital admission to 48 hours after initiation of treatment
Length of hospital stay
From hospital admission until hospital discharge, with follow-up assessment conducted up to 2 months after discharge
Study Arms (2)
Control Group
NO INTERVENTIONChildren with diabetic ketoacidosis who received routine hospital management according to standard hospital protocol without implementation of the evidence-based nursing guideline.
Intervention Group
OTHERChildren 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Children with comorbid chronic illnesses like congenital heart disease, renal failure, etc.
- Recurrent admission during the same study period (only first admission considered).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Raparin Pediatric Teaching Hospital
Erbil, Kurdistan Region, 44001, Iraq
Related Publications (1)
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.
BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Khaleed M Shaikhah, MSc
Hawler Medical University/ College of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 5, 2026
First Posted
March 12, 2026
Study Start
May 14, 2025
Primary Completion
December 1, 2025
Study Completion
February 1, 2026
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
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.