- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06748365
Serum Ferritin and Prognosis of DKA
May 8, 2025 updated by: Joseph Medhat Sobhy, Sohag University
Role of Ferritin in the Clinical Presentation and Short-Term Prognosis of Diabetic Ketoacidosis
the aim of this study is to: evaluate the association between serum ferritin levels and the clinical presentation and short-term prognosis of patients with DKA.
Specifically, the correlation between its level and the severity of DKA at presentation and determine its prognostic value in predicting short-term outcomes.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Ferritin studies and correlation to acute events like stroke or Mi was done before, however some studies have found a correlation with the degree and prognosis of these diseases and others not.
However no study was tried on DKA patients before so the investigators are trying to find if Ferritin would have a relation with patients of Dka and could be used as a prognostic tool (for example we found in this study when level is less than "200" patients mostly has good prognosis) this is just an example or (serrum ferritin turned out to be irrelevant to DKA prognosis as patients would have good prognosis despite number value) and this will be in selected patients according to criteria to exclude any chronic condition in the investigators hospital care units.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joseph Medhat Sobhy, resident in internal medicine
- Phone Number: +2001011041077
- Email: joeisgreatyeah@gmail.com
Study Contact Backup
- Name: Marium Medhat Sobhy, resident in opthalmology
- Phone Number: +2001023322977
- Email: mariummedhat3@gmail.com
Study Locations
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-
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Sohag, Egypt, 82524
- Recruiting
- Sohag university hospitals
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with DKA admitted to the emergency department or intensive care units of Sohag university Hospital
Description
Inclusion Criteria:
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All patients with DKA :
- Adult Aged 18 years old or older .
- Type 1 DM , type 2 DM
- Diagnosis of DKA based on the American Diabetes Association criteria: blood glucose >250 mg/dL, arterial pH <7.3, serum bicarbonate <18 mEq/L,
Exclusion Criteria:
- Patients age less than 18 years old
- Iron deficiency anemia and iron overload
- Chronic Inflammatory Diseases: Conditions such as rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease
- Acute and chronic infections, including bacterial, viral, and fungal infections
- Pt presented with other acute complication (MI,stroke)
- CKD patients
- Patients with chronic liver diseases
- Patients with malignancy
- Pregnant women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
evaluate the association between serum ferritin levels and the clinical presentation and short-term prognosis of patients with DKA. Specifically, the correlation between its level and the severity of DKA at presentation and determine its prognostic value
Time Frame: Through the study completion, an average of 1 year
|
Through the study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2025
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
February 1, 2026
Study Registration Dates
First Submitted
December 18, 2024
First Submitted That Met QC Criteria
December 21, 2024
First Posted (Actual)
December 27, 2024
Study Record Updates
Last Update Posted (Actual)
May 14, 2025
Last Update Submitted That Met QC Criteria
May 8, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med--24-12-07MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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