Severe Sepsis/Septic Shock on Admission to the General Surgical ICU

Study Overview
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Brief Summary
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Severe sepsis/septic shock are serious complications of infection with high morbidity and mortality. Recent information showed that early and aggressive resuscitation may help improving survival and outcome especially the resuscitation within the first 3 hours. In surgical patients, either severe sepsis/septic shock bought them to the operating room or this sepsis might be found after surgery resulting in higher morbidity and mortality. Not only knowledge management, others possible risk factors should also be identified and corrected for outcome improving. This prospective observational study will be done in 800 adult surgical patients admitting to the general surgical intensive care unit. Incidence of severe sepsis/septic shock on admission along with risk factors associated with poor outcomes [organ failure (AKI, ALI, PMI, liver failure, stroke), prolonged ICU length of, stay, ICU death] will be recorded especially effect of amount and type of fluid replacement in the first 6 hours, 24, 48 and 72 hours after diagnosis. Outcome as major organ failure, ICU length of stay, ICU, 28 and 90 days mortality will also be study.

Detailed Description
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Consecutive severe sepsis/ septic shock patients who will be admitted to the general surgical ICU of Siriraj Hospital, Mahidol University, Bangkok, Thailand will be recruited to this study. Apart from demographic data (age, sex, BMI, comorbidity), detail of septic shock and resuscitation (preoperative and intraoperative resuscitation), vasopressor and steroid used, type and amount of fluid, blood and blood component used and shock reversal time. Complication associated with surgery, anesthesia and in ICU will also recorded. Clinical outcome as organ failure (Stroke, PMI, aki, ARDS); ventilator day, ICU and hospital length of stay, mortality (in ICU, 28 and 90 days mortality) and cause of mortality will be carefully recorded

Official Title
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Severe Sepsis/Septic Shock on Admission to the General Surgical ICU

Conditions
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Septic Shock, Multiple Organ Failure, Fatal Outcome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (> 18 years) surgical patient admitting to the general surgical ICU Consent to this study Exclusion Criteria: Patient undergoing cardiothoracic surgery, neurosurgery and traumatic surgery Not consent to this study

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| severe sepsis<br>severe sepsis/septic shock, organ failure, ICU death | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of severe sepsis/septic shock on admission to the general surgical ICU | Incidence of severe sepsis and septic shock on admission to the general surgical ICU | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk factors associated with poor outcome (organ failure, prolonged ICU length of stay and ICU death) | organ failure (Stroke, AKI, PMI,ARDS), Mortality (ICU, 28 and 90 days) mortality and cause of mortality | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AKI, severe sepsis/septic shock, organ failure, PMI, ALI, Stroke, ICU death