Severe Sepsis/Septic Shock on Admission to the General Surgical ICU
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 28, 2011 | ||||||||
| Last Updated Date | June 2, 2011 | ||||||||
| Start Date ICMJE | June 2011 | ||||||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
incidence of severe sepsis/septic shock on admission to the general surgical ICU [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
incidence of severe sepsis/septic shock on admission to the general surgical ICU [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||||||
| Change History | Complete list of historical versions of study NCT01363635 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Severe Sepsis/Septic Shock on Admission to the General Surgical ICU | ||||||||
| Official Title ICMJE | Severe Sepsis/Septic Shock on Admission to the General Surgical ICU | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Adult surgical patient admiitiing to the general surgical ICU |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | severe sepsis
severe sepsis/septic shock, organ failure, ICU death |
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| Publications * | Zahar JR, Timsit JF, Garrouste-Orgeas M, Français A, Vésin 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 Apr 21; [Epub ahead of print] | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 800 | ||||||||
| Estimated Completion Date | July 2012 | ||||||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 19 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Thailand | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01363635 | ||||||||
| Other Study ID Numbers ICMJE | Si199/2011 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Prof. Suneerat Kongsayreepong, MD, Department of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol University,Bangkok, Thailand | ||||||||
| Study Sponsor ICMJE | Mahidol University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Mahidol University | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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