- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05914480
Sepsis in ICU:Causes and Outcomes in Diabetics and Non Diabetics
Sepsis in ICU: Causes and Outcomes in Diabetics and Non Diabetics in Assiut University Hospital
Identify prevalence of sepsis in ICU of Assiut university hospital 2.Clarify different causes of sepsis in patients admitted to ICU . 3.Compare causes and outcomes of sepsis between diabetics versus non diabetics .
4.Screening for the co1.mmonest organism causing sepsis in critically ill patients .
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sepsis, is defined as an infection with organ dysfunction, There is wide variation in sepsis rates, causative microorganisms, and outcome in ICU patients around the world.
Many conservative estimates considered sepsis as a leading cause of mortality and critical illness worldwide .
sepsis epidemiology studies worldwide revealed a highly variable incidence of 13-300 per 100,000 inhabitants per year for severe sepsis and 11 per 100,000 inhabitants per year for septic shock .
Factors such as advancing age, immunosuppression and multidrug-resistant infection play a role in increasing incidence of sepsis during recent decades .
Patients who survive sepsis often have long-term physical, psychological, and cognitive disabilities with significant health and social implications.
Patients with diabetes mellitus have an increased risk of developing infections and sepsis and they constitute 20.1-22.7% of all sepsis patients.
The prevalence of diabetes mellitus in ICU patients is as high as 30%, And such patients are at increased risk of experiencing in-hospital Complications, compared to patients without diabetes.
Infective complications may be reduced with lower blood glucose concentrations Moreover, in critically ill patients without diabetes, Hyperglycemia is associated with increased mortality, risk of infection, Kidney injury and cardiovascular complications.
Moreover, diabetes is a major risk factor for both Acute Kidney Injury and sepsis.
Sepsis also is a major cause of Acute Kidney Injury, which develops in one-fourth of all patients with sepsis and half of patients with bacteraemia or shock .
Sepsis-related AKI is associated with high mortality rates of up to 70%.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mai Ahmed fathi, Specialist
- Phone Number: 01009490399
- Email: doc.maiahmad89@gmail.com
Study Contact Backup
- Name: Hala khalafalla el sherif, Professor
- Phone Number: 01120110000
- Email: dr_hala_elshereef@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- according to sofa criteria Suspected /documented infection+sofa score >_2 or +ve Q sofa defined as 2or more 1_ hypotesion SBP<90.2_altered mental status GCS<13 3_ Exclusion Criteria:tachypnea>22 or septic shock criteria
- previous history of pulmonary problem Previous history of cardiac disease Previous history of autoimmune disease
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detect the most common organism causing sepsis in ICU
Time Frame: 20 days
|
Applying culture and sensitivity test for patients developed sepsis on admission and follow up will direct us for appropriate treatment for all patients
|
20 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of sepsis in diabetics versus non diabetics in ICU.
Time Frame: 15 days
|
Assess the effect of hyperglycemia on spsis outcomes.
|
15 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sepsis pts investigate causes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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