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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Mahidol University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01363635
First received: May 28, 2011
Last updated: June 2, 2011
Last verified: June 2011

May 28, 2011
June 2, 2011
June 2011
May 2012   (final data collection date for primary outcome measure)
incidence of severe sepsis/septic shock on admission to the general surgical ICU [ Time Frame: 1 year ] [ Designated as safety issue: No ]
incidence of severe sepsis/septic shock on admission to the general surgical ICU [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01363635 on ClinicalTrials.gov Archive Site
risk factors associated with poor outcome (organ failure, prolonged ICU length of stay and ICU death) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
risk factors associated with poor outcome (organ failure, prolonged ICU length of stay and ICU death [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Severe Sepsis/Septic Shock on Admission to the General Surgical ICU
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 with goal directed therapy help improving survival and outcome especially the resuscitation within the first 6 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. Knowledge about severe sepsis/septic shock was implemented among the associated personal, outcome as major organ failure, ICU length of stay, ICU death will also be compare between this prospective study and historical controlled.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Adult surgical patient admiitiing to the general surgical ICU

  • Septic Shock
  • Multiple Organ Failure
  • Fatal Outcome
Not Provided
severe sepsis
severe sepsis/septic shock, organ failure, ICU death
Zahar JR, Timsit JF, Garrouste-Orgeas M, Français 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, Aurélien [corrected to Vesin, Aurélien].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
800
July 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
19 Years to 90 Years
No
Contact: Suneerat Kongsayreepong, MD (661) 8427419 sisko@mahidol.ac.th
Contact: Onuma Chaiwat, MD (664)-3882104 sioca@mahidol.ac.th
Thailand
 
NCT01363635
Si199/2011
No
Prof. Suneerat Kongsayreepong, MD, Department of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol University,Bangkok, Thailand
Mahidol University
Not Provided
Principal Investigator: Suneerat Kongsayreepong, MD Department of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol University, Bnagkok, Thailand
Mahidol University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP