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Impact of Clinical Nursing Guideline on Outcomes of Children With Diabetic Ketoacidosis.

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07467616
Acronym
PED-DKA
Enrollment
60
Registered
2026-03-12
Start date
2025-05-14
Completion date
2026-02-01
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Ketoacidosis

Keywords

Pediatric Diabetic Ketoacidosis, Evidence-Based Nursing Guideline, Type I Diabetic, Pediatric Emergency Care, Pediatric Critical Care Nursing, Management of Diabetic Ketoacidosis

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.

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.

Interventions

OTHEREvidence-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.

Sponsors

Hawler Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants were assigned to two groups: a control group receiving routine hospital management of pediatric diabetic ketoacidosis and an intervention group receiving care based on an evidence-based clinical nursing guideline. Clinical outcomes were compared between the two groups.

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Resolution Time of Diabetic ketoacidosisFrom 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.

Secondary

MeasureTime frameDescription
Blood glucose levelFrom hospital admission to 48 hours after initiation of treatmentChange in blood glucose level during treatment of DKA, unitl return to normal standard level.
Length of hospital stayFrom hospital admission until hospital discharge, with follow-up assessment conducted up to 2 months after dischargeTotal duration of hospital stay measured in days from admission until discharge of child to home.

Countries

Iraq

Contacts

PRINCIPAL_INVESTIGATORKhaleed M Shaikhah, MSc

Hawler Medical University/ College of Nursing

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026