Clinical trial NCT04015752: Sepsis in ICU:Causes and Outcomes of Sepsis in Diabetics Versus Non Diabetics in Assiut University Hospital
Official title: Sepsis in Intensive Care Unit :Causes and Outcomes of Sepsis in Diabetics Versus Non Diabetics in Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Septic Shock
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to ICU and devoloped sepsis or septic shock (even on admission or later-on ) as defined by 3rd consensus guidelines (sepsis 3) ,2016 patients then devided into 3 groups : Group 1: patients with Diabetes Mellitus (type 1or type 2). Group 2: patients with in-hospital hyperglycemia(not known to be diabetic). Group 3 : Normglycemic patients (without past or present history of DM ).

Brief summary: Clarify different causes of sepsis in patients admitted to ICU . as well asCompare causes and outcomes of sepsis between diabetics versus non diabetics .

3.Screening for the commonest organism causing sepsis in critically ill patients.

Determine better protocol therapy that help in decreasing mortality and morbidity in patients with sepsis in ICU.

Detailed description: Sepsis is a physiologic, pathologic, and biochemical abnormalities induced by infection.

sepsis is considered as a leading cause of mortality and critical illness worldwide by many conservative estimates.

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 multi-drug-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.

Infection also remains an important cause of death in diabetics. The prevalence of diabetes mellitus in Intensive Care Unit 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 bacteremia or shock .

Sepsis-related Acute Kidney Injury is associated with high mortality rates of up to 70%.

Eligibility criteria: Inclusion Criteria:

patients admitted to ICU for any reason and devoloped sepsis either on admission or later during thier hospital stay. patients having Criteria of sepsis or septic shock as defined by 3rd consensus guidelines (sepsis 3) ,2016

Exclusion Criteria:

Previous history of pulmonary problem . Previous history of cardiac disease. Previous history of Autoimmune disease immunocompromised patients

Primary outcomes:
measure: detect the most common organism causing sepsis in ICU .
timeFrame: 20 days
Secondary outcomes:
measure: incidence of sepsis in diabetics versus non diabetics in ICU.
timeFrame: 15 days
Other outcomes:
Locations:
Study officials:
References:
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