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

NCT01363635 | Unknown

• 1 other identifier: Si199/2011
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Multiple Organ Failure; Fatal Outcome

Keywords

severe sepsis/septic shock; organ failure; AKI; PMI; ALI; Stroke; ICU death

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• risk factors associated with poor outcome (organ failure, prolonged ICU length of stay and ICU death)

  5 year

Study Arms (1)

severe sepsis

severe sepsis/septic shock, organ failure, ICU death

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult surgical patient admiitiing to the general surgical ICU

You may qualify if:

• Adult (\> 18 years) surgical patient admitting to the general surgical ICU
• Consent to this study

You may not qualify if:

• Patient undergoing cardiothoracic surgery, neurosurgery and traumatic surgery
• Not consent to this study

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

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

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (1)

• 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.

  PMID: 21516036 RESULT

MeSH Terms

Conditions

Shock, Septic; Multiple Organ Failure; Sepsis; Stroke

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Suneerat Kongsayreepong, MD

  Siriraj Hospital, Mahidol University, Bnagkok, Thailand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suneerat Kongsayreepong, MD

CONTACT

(661) 8427419; suneerat.kon@mahidol.ac.th

Onuma Chaiwat, MD

CONTACT

(664)-3882104; onuma27@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2011
• First Posted: June 1, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

TH (1)