Diabetic KetoacidosisNCT06599203
Children with Diabetic Ketoacidosis
An observational study of Diabetic Ketoacidosis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Diabetic Ketoacidosis
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 31 Jan 2026
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Hospitalized diabetic patients aged from 1 year to 16 years with diabetic ketoacidosis
Who cannot join
- Other endocrine diseases as thyroid disease or pituitary disease
- Severe Hepatic Dysfunction or Chronic Kidney Dysfunction: Patients with significant liver or kidney impairment were excluded from the study.
- History of Malignant Tumor: The study did not include individuals with a previous history of any malignant tumor
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prognostic Factors in Children with Diabetic Ketoacidosis
In the present work we aim to
- 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.
- Clinical complication like cerebral injury / cerebral edema , cognitive impairment , acute kidney injury , hypokalemia.
- 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)
- Conditions
- Diabetic Ketoacidosis
- Medical subject headings
- Diabetic Ketoacidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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%.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Diaa Eldin Mahmoud sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599203
- Sponsor's protocol ID
- diabetic ketoacidosis
- Status last verified
- Sep 2024
- First submitted
- 7 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors in Children with Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT06599203
- Acronym / sponsor ID
- diabetic ketoacidosis
- Conditions
- Diabetic Ketoacidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
In the present work we aim to
- 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.
- Clinical complication like cerebral injury / cerebral edema , cognitive impairment , acute kidney injury , hypokalemia.
- Severity of DKA
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Hospitalized diabetic patients aged from 1 year to 16 years with diabetic ketoacidosis
Key exclusion criteria (3 listed)
- Other endocrine diseases as thyroid disease or pituitary disease
- Severe Hepatic Dysfunction or Chronic Kidney Dysfunction: Patients with significant liver or kidney impairment were excluded from the study.
- History of Malignant Tumor: The study did not include individuals with a previous history of any malignant tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Method
Time frame: Baseline
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.
Sample size
Time frame: Baseline
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%.
Determination of response to therapy and clinical complication of DKA
Time frame: Baseline
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Ketoacidosis, run by Assiut University.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Diaa Eldin khedr, Bachelor of Medicine (01119989237, ahmeddiaa274@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Method (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.