Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-29 @ 9:23 AM
Study NCT ID:
NCT06599203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Children with Diabetic Ketoacidosis
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Prognostic Factors in Children with Diabetic Ketoacidosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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)
, 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: