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

Recruiting

• Conditions: Septic Shock; Multiple Organ Failure; Fatal Outcome

• Registration Number: NCT01363635
• Lead Sponsor: Mahidol University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2011-05-28
• Study First Submitted QC: 2011-05-28
• Study Start: 2011-06
• Study First Posted: 2011-06-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-10-31
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of severe sepsis/septic shock on admission to the general surgical ICU	5 year	Incidence of severe sepsis and septic shock on admission to the general surgical ICU

Secondary Outcome Measures

Name	Time	Method
risk factors associated with poor outcome (organ failure, prolonged ICU length of stay and ICU death)	5 year	organ failure (Stroke, AKI, PMI,ARDS), Mortality (ICU, 28 and 90 days) mortality and cause of mortality

Trial Locations

Locations (1)

ICU Siamitra and ICU salad-Sumang, Deaprtment of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol UNiversity, Bangkok, Thailand; 🇹🇭 Bangkoknoi, Bangkok, Thailand