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

NCT ID: NCT01363635

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2024-06-30

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

Conditions

Septic Shock; Multiple Organ Failure; Fatal Outcome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

severe sepsis

severe sepsis/septic shock, organ failure, ICU death

No interventions assigned to this group

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Suneerat Kongsayreepong, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suneerat Kongsayreepong, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital, Mahidol University, Bnagkok, Thailand

Locations

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

Bangkoknoi, Bangkok, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Suneerat Kongsayreepong, MD

Role: CONTACT

suneerat.kon@mahidol.ac.th

(661) 8427419

Onuma Chaiwat, MD

Role: CONTACT

onuma27@hotmail.com

(664)-3882104

Facility Contacts

Suneerat Kongsayreepong, MD

Role: primary

suneerat.kon@mahidol.ac.th

(661) 8427419

Onuma Chailwat, MD

Role: backup

onuma27@hotmail.com

(664)-3882104

References

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.

Reference Type: RESULT

PMID: 21516036 (View on PubMed)

Other Identifiers

Si199/2011

Identifier Type: -

Identifier Source: org_study_id