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RecruitingNCT01363635Updated Oct 31, 2023

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

An observational study in Septic Shock, Multiple Organ Failure and Fatal Outcome, sponsored by Mahidol University. Recruiting at 1 site in Thailand. Open to participants aged 19 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by Mahidol University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Started Jun 2011; still recruiting 15 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
19 Years to 90 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Septic Shock
  • Multiple Organ Failure
  • Fatal Outcome

Keywords

  • severe sepsis/septic shock
  • organ failure
  • AKI
  • PMI
  • ALI
  • Stroke
  • ICU death
03

In context

Shock, Septic

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's planned enrollment of 800 is above the median of 108 across 406 observational studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult surgical patient admiitiing to the general surgical ICU

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient undergoing cardiothoracic surgery, neurosurgery and traumatic surgery
  • Not consent to this study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)

Groups and cohorts

  • severe sepsis

    severe sepsis/septic shock, organ failure, ICU death

06

What researchers measure

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

    Time frame: 5 year

Secondary outcomes

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

    organ failure (Stroke, AKI, PMI,ARDS), Mortality (ICU, 28 and 90 days) mortality and cause of mortality

    Time frame: 5 year

07

Study locations

1 of 1 sites recruiting
  • ICU Siamitra and ICU salad-Sumang, Deaprtment of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol UNiversity, Bangkok, Thailand
    Bangkoknoi, Bangkok 10700, Thailand
    Recruiting
08

References and documents

Publications

  • 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. Erratum In: Crit Care Med. 2011 Oct;39(10):2392. Vesim, Aurelien [corrected to Vesin, Aurelien]. PubMed 21516036 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01363635
Lead sponsor
Mahidol University
Responsible party
Suneerat Kongsayreepong, MD (Professor, Mahidol University) — Principal investigator
First posted
Jun 1, 2011
Start date
Jun 2011
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Oct 31, 2023

Study contacts

Suneerat Kongsayreepong, MD
Contact
suneerat.kon@mahidol.ac.th
(661) 8427419
Onuma Chaiwat, MD
Contact
onuma27@hotmail.com
(664)-3882104
Suneerat Kongsayreepong, MD
principal investigator · Siriraj Hospital, Mahidol University, Bnagkok, Thailand

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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