Clinical trial NCT01363635: Severe Sepsis/Septic Shock on Admission to the General Surgical ICU
Official title: Severe Sepsis/Septic Shock on Admission to the General Surgical ICU
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Septic Shock
Multiple Organ Failure
Fatal Outcome
Keywords: severe sepsis/septic shock
organ failure
AKI
PMI
ALI
Stroke
ICU death
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-06-01
Enrollment: 800
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult surgical patient admiitiing to the general surgical ICU

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

Eligibility criteria: 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

Primary outcomes:
measure: incidence of severe sepsis/septic shock on admission to the general surgical ICU
timeFrame: 5 year
Secondary outcomes:
measure: risk factors associated with poor outcome (organ failure, prolonged ICU length of stay and ICU death)
timeFrame: 5 year
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: ICU Siamitra and ICU salad-Sumang, Deaprtment of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol UNiversity, Bangkok, Thailand
state: Bangkok
Study officials:
affiliation: Siriraj Hospital, Mahidol University, Bnagkok, Thailand
name: Suneerat Kongsayreepong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zahar JR, Timsit JF, Garrouste-Orgeas M, Francais A, Vesin A, Descorps-Declere A, Dubois Y, Souweine B, Haouache H, Goldgran-Toledano D, Allaouchiche B, Azoulay E, Adrie C. Outcomes in severe sepsis and patients with septic shock: pathogen species and infection sites are not associated with mortality. Crit Care Med. 2011 Aug;39(8):1886-95. doi: 10.1097/CCM.0b013e31821b827c.