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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Suneerat Kongsayreepong, MD; Phone Number: (661) 8427419; Email: suneerat.kon@mahidol.ac.th
• Study Contact Backup: Name: Onuma Chaiwat, MD; Phone Number: (664)-3882104; Email: onuma27@hotmail.com

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Recruiting
      • ICU Siamitra and ICU salad-Sumang, Deaprtment of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol UNiversity, Bangkok, Thailand
      • Contact: Suneerat Kongsayreepong, MD; Phone Number: (661) 8427419; Email: suneerat.kon@mahidol.ac.th
      • Contact: Onuma Chailwat, MD; Phone Number: (664)-3882104; Email: onuma27@hotmail.com
      • Principal Investigator: Suneerat Kongsayreepong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult surgical patient admiitiing to the general surgical ICU

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
severe sepsis; severe sepsis/septic shock, organ failure, ICU death

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Suneerat Kongsayreepong, MD, Siriraj Hospital, Mahidol University, Bnagkok, Thailand

Publications and helpful links

General Publications

• 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. Erratum In: Crit Care Med. 2011 Oct;39(10):2392. Vesim, Aurelien [corrected to Vesin, Aurelien].

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 28, 2011
• First Submitted That Met QC Criteria: May 28, 2011
• First Posted (Estimated): June 1, 2011

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; ALI; AKI; organ failure; severe sepsis/septic shock; PMI; ICU death
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock; Multiple Organ Failure
• Other Study ID Numbers: Si199/2011