Septic Shock Clinical Trial
Official title:
Severe Sepsis/Septic Shock on Admission to the General Surgical ICU
NCT number | NCT01363635 |
Other study ID # | Si199/2011 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2011 |
Est. completion date | June 2024 |
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.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | ICU Siamitra and ICU salad-Sumang, Deaprtment of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol UNiversity, Bangkok, Thailand | Bangkoknoi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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 inf — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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