Diabetic KetoacidosisPED-DKANCT07467616
Impact of Clinical Nursing Guideline on Outcomes of Children With Diabetic Ketoacidosis.
A study testing Evidence-Based Nursing Guideline for Children with Diabetic Ketoacidosos in people with Diabetic Ketoacidosis, run by Hawler Medical University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Diabetic Ketoacidosis
- What is being tested?
- Evidence-Based Nursing Guideline for Children with Diabetic Ketoacidosos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 14 May 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children with comorbid chronic illnesses like congenital heart disease, renal failure, etc.
- Recurrent admission during the same study period (only first admission considered).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Ketoacidosis
- Being tested
- Evidence-Based Nursing Guideline for Children with Diabetic Ketoacidosos
- Keywords
- Pediatric Diabetic Ketoacidosis, Evidence-Based Nursing Guideline, Type I Diabetic, Pediatric Emergency Care, Pediatric Critical Care Nursing, Management of Diabetic Ketoacidosis
- Medical subject headings
- Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-Based Nursing Guideline for Children with Diabetic KetoacidososOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Children with diabetic ketoacidosis who received routine hospital management according to standard hospital protocol without implementation of the evidence-based nursing guideline. |
| Intervention Group | Other | 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. Receives: Other: Evidence-Based Nursing Guideline for Children with Diabetic Ketoacidosos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Change in blood glucose level during treatment of DKA, unitl return to normal standard level.
Measured: From hospital admission to 48 hours after initiation of treatment
Length of hospital stay
Total duration of hospital stay measured in days from admission until discharge of child to home.
Measured: From hospital admission until hospital discharge, with follow-up assessment conducted up to 2 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start14 May 2025
- Primary completion1 Dec 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaleed Mohammed Shaikhah, Hawler Medical University
- Investigators
- Khaleed M Shaikhah, MSc, Principal investigator, Hawler Medical University/ College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467616
- Sponsor's protocol ID
- PED-DKA-GUIDELINE-2026
- Acronym
- PED-DKA
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Wright N, Thomas R. BSPED guideline: what we know and why the guideline was changed. Arch Dis Child Educ Pract Ed. 2021 Aug;106(4):226-228. doi: 10.1136/archdischild-2020-320077. Epub 2021 Mar 3. No abstract available.
PubMed 33658290
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Evidence-Based Practice Nursing Guideline on Clinical Outcomes in Children With Diabetic Ketoacidosis: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07467616
- Acronym / sponsor ID
- PED-DKA / PED-DKA-GUIDELINE-2026
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Children with diabetic ketoacidosis who received routine hospital management according to standard hospital protocol without implementation of the evidence-based nursing guideline. |
| Intervention Group | Other | Other: Evidence-Based Nursing Guideline for Children with Diabetic KetoacidososChildren 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Children with comorbid chronic illnesses like congenital heart disease, renal failure, etc.
- Recurrent admission during the same study period (only first admission considered).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evidence-Based Nursing Guideline for Children with Diabetic KetoacidososImplementation 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. | Other | Intervention Group |
Primary outcome
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.
2 secondary outcomes
Blood glucose level
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 33658290Wright N, Thomas R. BSPED guideline: what we know and why the guideline was changed. Arch Dis Child Educ Pract Ed. 2021 Aug;106(4):226-228. doi: 10.1136/archdischild-2020-320077. Epub 2021 Mar 3. No abstract available.
- BSPED is a guideline that used for managing children with DKALink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaleed M Shaikhah, MSc principal investigator
Hawler Medical University/ College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-Based Nursing Guideline for Children with Diabetic Ketoacidosos in people with Diabetic Ketoacidosis, run by Hawler Medical University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07467616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.