Sepsis in ICU:Causes and Outcomes of Sepsis in Diabetics Versus Non Diabetics in Assiut University Hospital

• Conditions: Sepsis; Septic Shock
• Interventions: Diagnostic Test: culture from infected site

• Registration Number: NCT04015752
• Lead Sponsor: Assiut University

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%.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-09
• Last Update Submitted: 2019-07-10
• Study First Posted: 2019-07-11
• Last Update Posted: 2019-07-12
• Study Start: 2019-08
• Primary Completion: 2020-07
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non diabetics	culture from infected site	1. Full history with special attention to: Causes of admission to ICU . Duration of DM when present medication used, controlled or not. 2. Complete physical examination with special attention to : Vital signs ( MAP, pulse, temp, RR) Signs of shock (cold clammy skin , oliguria, altered mental status ) Consciousness level. Source of infection (chest , abdomen ,catheter, JV canula,..). 3. Laboratory investigations CBC , Liver and kidney functions → baseline and follow up HBA1C. ESR, CRP →baseline and follow up. Culture : On admission Urine and blood as well as sputum culture acc. To the cause of infection. Culture from suspected site of infection in catheter related infections.
patients devoloped hyperglycemia in ICU only	culture from infected site	Full history with special attention to: Causes of admission to ICU . Duration of DM when present medication used, controlled or not. 2. Complete physical examination with special attention to : Vital signs ( MAP, pulse, temp, RR) Signs of shock (cold clammy skin , oliguria, altered mental status ) Consciousness level. Source of infection (chest , abdomen ,catheter, CVP,..). 3. Laboratory investigations CBC , Liver and kidney functions → baseline and follow up HBA1C. ESR, CRP →baseline and follow up. Culture : On admission Urine and blood as well as sputum culture acc. To the cause of infection. Culture from suspected site of infection in catheter related infections.
diabetics	culture from infected site	1. Full history with special attention to: Causes of admission to ICU . Duration of DM when present, medication used, controlled or not. 2. Complete physical examination with special attention to : Vital signs ( MAP, pulse, temp, RR). Signs of shock (cold clammy skin , oliguria, altered mental status ) Consciousness level. Source of infection (chest , abdomen ,catheter, JV canula,..). 3. Laboratory investigations includes : CBC , Liver and kidney functions → baseline and follow up. Arterial Blood Gases (ABG). Lactic acid level. HBA1C. ESR, CRP →baseline and follow up. Culture : On admission Urine and blood as well as sputum culture acc. To the cause of infection. Culture from suspected site of infection in catheter related infections.

Primary Outcome Measures

Name	Time	Method
detect the most common organism causing sepsis in ICU .	20 days	applying culture and sensitivity tests for patients developed sepsis on admission and follow up will direct us to the proper treatment protocol for all patients.

Secondary Outcome Measures

Name	Time	Method
incidence of sepsis in diabetics versus non diabetics in ICU.	15 days	Asses the effect of hyperglycemia on sepsis outcomes.