Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-28 @ 8:36 AM
Study NCT ID:
NCT01363635
Status:
UNKNOWN
Last Update Posted:
2023-10-31
First Post:
2011-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe Sepsis/Septic Shock on Admission to the General Surgical ICU
Sponsor:
Mahidol University
Organization:
Study Overview
Official Title:
Severe Sepsis/Septic Shock on Admission to the General Surgical ICU
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: