NCT06748365

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

May 14, 2025

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 18, 2024

Last Update Submit

May 8, 2025

Conditions

Keywords

serum FerritinDiabetic Ketoacidosis

Outcome Measures

Primary Outcomes (1)

  • 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

    Through the study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with DKA admitted to the emergency department or intensive care units of Sohag university Hospital

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospitals

Sohag, Sohag Governorate, 82524, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetic Ketoacidosis

Condition Hierarchy (Ancestors)

KetosisAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Central Study Contacts

Joseph Medhat Sobhy, resident in internal medicine

CONTACT

Marium Medhat Sobhy, resident in opthalmology

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at internal medicine department

Study Record Dates

First Submitted

December 18, 2024

First Posted

December 27, 2024

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

May 14, 2025

Record last verified: 2024-12

Locations