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Not yet recruitingNCT06599203Updated Sep 19, 2024

Children with Diabetic Ketoacidosis

An observational study in Diabetic Ketoacidosis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
1 Year to 18 Years
Sex
All
01

Study summary

In the present work we aim to

  1. Response to therapy, During the management of DKA, acid base status, glycemia, and serum electrolytes are measured frequently to monitor the efficacy of treatment, detect complications of DKA and its treatment, and to determine resolution of DKA.
  2. Clinical complication like cerebral injury / cerebral edema , cognitive impairment , acute kidney injury , hypokalemia.
  3. Severity of DKA
Read the detailed description

Diabetic ketoacidosis (DKA) is a life-threatening condition, especially in individuals with Type 1 diabetes. It arises from a severe insulin deficiency, resulting in elevated blood glucose levels . In reaction, the body begins metabolizing fat for energy

, which causes the production of ketones. Ketone buildup in the blood results in metabolic acidosis, which produces symptoms including extreme thirst, frequent urination, stomach discomfort, nausea, vomiting, disorientation, and breath that smells like fruit .A chronic autoimmune disease known as Type 1 Diabetes Mellitus (T1DM) is characterized by the eradication of insulin-producing beta cells in the pancreas. Although it may happen at any age, it often starts to manifest in childhood or adolescent . In T1DM, the immune system incorrectly targets and kills the beta cells, leading to little or nonexistent insulin production . The hormone insulin is essential for controlling blood glucose levels . Because of this, T1DM patients need lifelong insulin medication in order to survive. Excessive thirst, frequent urination, exhaustion, and an increased susceptibility to infections are all typical signs of T1DM . The treatment of T1DM entails routine blood glucose monitoring, the use of insulin pumps or injections, a balanced diet, routine physical exercise, and the management of additional risk factors for complications .DKA is diagnosed based on clinical presentation and biochemical abnormalities, including hyperglycemia (blood glucose >200 mg/dL), venous pH of \<7.3 or serum bicarbonate less than 15, and the presence of ketones in the blood or urine. Ill patients with Type-1 DM should be evaluated for DKA, which can coexist with or be triggered by other acute illnesses (infection, trauma, etc.). There may be a history of polydipsia, polyuria, polyphagia (early), anorexia (late), weight loss, fatigue, or recurrent infection. Patients and parents may also report poor school performance, lack of concentration, altered mental status, and confusion as well.Patients with metabolic acidosis classically display rapid, deep breathing (Kussmaul respirations). The breath may have a fruity odor due to respiratory aceton elimination. Neurologic findings range from alert, to lethargic and drowsy, to comatose correlated with the extent of acidosis. In order to treat DKA and prevent life-threatening consequences, immediate medical intervention essential. DKA calls for intravenous fluids, insulin therapy, and correction of electrolyte imbalances. It is indeed crucial to study Diabetic Ketoacidosis (DKA), its incidence, and the features of hospital admissions in order to understand and improve the management of this condition . Delayed treatment altered sensorium , lower bicarbonate , lower pH , elevated urea , elevated creatinine , higher sodium levels at admission are significant risk factors for mortality among children with diabetic keto acidosis at initial presentation .Majority of these factors signify severe disease , and this could be aggravated by delay in recognition and treatment. Overall mortality among children presenting with DKA as the initial presentation in type 1 Diabetes mellitus is 12.8% . (14)

02

Conditions studied

  • Diabetic Ketoacidosis

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03

In context

Diabetic Ketoacidosis

76 studies on the registry are indexed under Diabetic Ketoacidosis; 17 are open to participants now.

This study's planned enrollment of 130 is above the median of 100 across 29 observational studies indexed under Diabetic Ketoacidosis.

Browse Diabetic Ketoacidosis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with type 1 DM with clinical presentation and biochemical abnormalities, including hyperglycemia (blood glucose200 mg/dL), venous pH less than7.3 or serum bicarbonate less than 15, and the presence of ketones in the blood or urine (12). Ill patients with Type-1 DM should be evaluated for DKA, which can coexist with or be triggered by other acute illnesses (infection, trauma, etc.). There may be a history of polydipsia, polyuria, polyphagia (early), anorexia (late), weight loss, fatigue, or recurrent infection.

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Inclusion criteria

Hospitalized diabetic patients aged from 1 year to 16 years with diabetic ketoacidosis

Exclusion criteria

Exclusion Criteria:

  1. Other endocrine diseases as thyroid disease or pituitary disease
  2. Severe Hepatic Dysfunction or Chronic Kidney Dysfunction: Patients with significant liver or kidney impairment were excluded from the study.
  3. History of Malignant Tumor: The study did not include individuals with a previous history of any malignant tumor
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Method

    Full history taking in the form of personal history age ,sex ,demographics including residence and socioeconomic status , feeding history ,family history . complete physical examination including body temperature , respiratory rate heart rate , weight , skin color . laboratory investigations including random blood glucose , ketones in urine , arterial blood gases ,complete blood count , electrolytes , kidney function test , liver function test. They will be managed with standard care that include insulin, intravenous fluids, and appropriate supportive care. Serial assays of serum electrolytes, glucose, and blood pH were analyzed and correlated with clinical outcomes of either discharge to home or death.

    Time frame: Baseline

  2. Sample size

    Based on determining the primary outcome variable, the estimated minimum required sample size is 130 patients. The sample size shall be calculated using Epi-info version 7 software based on the following hypothesis: The primary outcome variable correlates the final outcome in diabetic ketoacidosis with different confounding covariates such as demographic characteristics, clinical characteristics, and biochemical parameters at presentation. Based on previous studies (H Zayed 2016 ), the prevalence of DKA in Egypt was 17 % and based on the percentage confidence limits of 5% and a confidence level = 90%.

    Time frame: Baseline

  3. Determination of response to therapy and clinical complication of DKA

    Response to therapy during the management of DKA is determined by measuring acid base status, glycemia, and serum electrolytes, venous PH, serum bicarbonate concentration HCO3(mmol/ml), anion gap AG and urine ketones frequently to monitor the efficacy of treatment, detect complications of DKA and its treatment, and to determine resolution of DKA.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2024; primary completion for Dec 2025, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2024
First posted
Sep 19, 2024
StartEst.
Oct 1, 2024
Primary completionEst.
Dec 31, 2025
CompletionEst.
Jan 31, 2026
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06599203
Lead sponsor
Assiut University
Responsible party
Ahmed Diaa Eldin Mahmoud sayed (71515,Assiut, Assiut University) — Principal investigator
First posted
Sep 19, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

Ahmed Diaa Eldin khedr, Bachelor of Medicine
Contact
ahmeddiaa274@gmail.com
01119989237
Rehab Ibrahim Hassan, Lecture
Contact
rehab.refaat@aun.edu.eg
01009272624

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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