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Completed

NCT Number: NCT07467616

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

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.

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Key information

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Raparin Pediatric Teaching Hospital

Erbil, Kurdistan Region, 44001, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Evidence-Based Nursing Guideline for Children with Diabetic Ketoacidosos

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

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

Acronym: PED-DKA

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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