We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01363635
Recruitment Status : Unknown
Verified June 2011 by Mahidol University.
Recruitment status was:  Not yet recruiting
First Posted : June 1, 2011
Last Update Posted : June 6, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease
Septic Shock Multiple Organ Failure Fatal Outcome

Study Design

Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Severe Sepsis/Septic Shock on Admission to the General Surgical ICU
Study Start Date : June 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. incidence of severe sepsis/septic shock on admission to the general surgical ICU [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. risk factors associated with poor outcome (organ failure, prolonged ICU length of stay and ICU death) [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult surgical patient admiitiing to the general surgical ICU
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363635


Contacts
Contact: Suneerat Kongsayreepong, MD (661) 8427419 sisko@mahidol.ac.th
Contact: Onuma Chaiwat, MD (664)-3882104 sioca@mahidol.ac.th

Locations
Thailand
ICU Siamitra and ICU salad-Sumang, Deaprtment of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol UNiversity, Bangkok, Thailand Not yet recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Suneerat Kongsayreepong, MD    (661) 8427419    sisko@mahidol.ac.th   
Contact: Onuma Chailwat, MD    (664)-3882104    sioca@mahidol.ac.th   
Principal Investigator: Suneerat Kongsayreepong, MD         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Suneerat Kongsayreepong, MD Department of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol University, Bnagkok, Thailand
More Information

Publications:
Responsible Party: Prof. Suneerat Kongsayreepong, MD, Department of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol University,Bangkok, Thailand
ClinicalTrials.gov Identifier: NCT01363635     History of Changes
Other Study ID Numbers: Si199/2011
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: June 6, 2011
Last Verified: June 2011

Keywords provided by Mahidol University:
severe sepsis/septic shock
organ failure
AKI
PMI
ALI
Stroke
ICU death

Additional relevant MeSH terms:
Sepsis
Shock
Shock, Septic
Multiple Organ Failure
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes