Children with Diabetic Ketoacidosis

NCT06599203 | Not Yet Recruiting

• 1 other identifier: diabetic ketoacidosis
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the present work we aim to

1. 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. 2.Clinical complication like cerebral injury / cerebral edema , cognitive impairment , acute kidney injury , hypokalemia.
3. 3.Severity of DKA

Conditions

Diabetic Ketoacidosis

Outcome Measures

Primary Outcomes (3)

• 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.

  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%.

  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.

  Baseline

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Diabetic Ketoacidosis

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Ahmed Diaa Eldin khedr, Bachelor of Medicine

CONTACT

01119989237; ahmeddiaa274@gmail.com

Rehab Ibrahim Hassan, Lecture

CONTACT

01009272624; rehab.refaat@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 71515,Assiut

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09