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CompletedNCT01354197THAI-SICUUpdated Mar 27, 2017Results posted

The Thai Surgical Intensive Care Study (Thai-SICU Study)

An observational study in Complications of Surgical and Medical Care: General Terms, Adverse Reaction to Drug and Sequelae of External Causes of Morbidity and Mortality, sponsored by Royal College of Anesthesiologists of Thailand. Completed at 9 sites in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-27.

Sponsored by Royal College of Anesthesiologists of Thailand · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,652
Ages
18 Years and older
Sex
All
01

Study summary

The study observed the 28 days mortality of 9 participated University base surgical intensive care unit (SICU) as well as the occurrence of adverse events in SICU.

Read the detailed description

The adverse events included pulmonary aspiration, pulmonary emboli, drug error, new stroke, symptomatic deep vein thrombosis, pneumothorax, unplanned extubation, upper GI hemorrhage, myocardial infarction, abdominal hypertension, acute lung injury(ALI)/acute respiratory distress syndrome (ARDS), re-intubation within 72 hours, delirium, cardiac arrest, new arrhythmia, acute kidney injury, sepsis

02

Conditions studied

  • Complications of Surgical and Medical Care: General Terms
  • Adverse Reaction to Drug
  • Sequelae of External Causes of Morbidity and Mortality
  • Critical Illness

Keywords

  • Adverse events
  • Mortality
  • Readmission
  • Surgical intensive care unit
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 4,652 is above the median of 130 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

This is the only study on the registry with Royal College of Anesthesiologists of Thailand as lead sponsor.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All SICU admission patients

Inclusion criteria

  • All SICU admission patients

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,652 participants (actual)

Groups and cohorts

  • All ICU admission patients

    All ICU admission to surgical intensive care unit at cohort time

06

What researchers measure

Primary outcomes

  1. Overall Mortality

    Number of Participants who Did Not Survive up to 28 days after surgical ICU admission

    Time frame: 28 days

Secondary outcomes

  1. Readmission to ICU

    Number of Participants with Readmission to ICU up to 3 days (72 hours) after discharge from ICU

    Time frame: 3 days

07

Results

Posted Mar 27, 2017

Participant flow

Participant flow — Overall Study
MilestoneAll ICU Admission Patients
Started4652
Completed4652
Not completed0

Outcome measures

PrimaryOverall Mortality

Number of Participants who Did Not Survive up to 28 days after surgical ICU admission

Time frame:
28 days
Reported as:
Number · participants
Overall Mortality
participantsAll ICU Admission Patients
Overall Mortality642
SecondaryReadmission to ICU

Number of Participants with Readmission to ICU up to 3 days (72 hours) after discharge from ICU

Time frame:
3 days
Reported as:
Number · participants
Readmission to ICU
participantsAll ICU Admission Patients
Readmission to ICU144

Adverse events

Collected over Up to 28 days after surgical ICU admission. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Survive at Day 28—1,070/4,010 (26.7%)253/4,010 (6.3%)
Non-survive at Day 28—519/642 (80.8%)90/642 (14%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventSurvive at Day 28Non-survive at Day 28
SepsisInfections and infestations607/4010300/642
Acute kidney injuryRenal and urinary disorders491/4010295/642
Cardiac arrestCardiac disorders17/4010209/642
Acute lung injury/ Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders119/4010119/642
New arrhythmiaCardiac disorders184/4010103/642
Upper gastrointestinal hemorrhageGastrointestinal disorders33/401022/642
SeizureNervous system disorders26/401019/642
Myocardial infarctionCardiac disorders47/401019/642
Intra-abdominal hypertensionGastrointestinal disorders54/401017/642
New strokeNervous system disorders9/40102/642
Most frequent other events
Most frequent other events
EventSurvive at Day 28Non-survive at Day 28
DeliriumNervous system disorders117/401046/642
Reintubation within 72 hoursRespiratory, thoracic and mediastinal disorders112/401029/642
Unplanned extubationRespiratory, thoracic and mediastinal disorders41/401016/642
PneumothoraxRespiratory, thoracic and mediastinal disorders14/401011/642
Symptomatic deep venous thrombosisVascular disorders10/40104/642
Self reported medication errorSurgical and medical procedures7/40103/642
Pulmonary aspirationRespiratory, thoracic and mediastinal disorders2/40101/642

Baseline characteristics

Age, Continuous
Age, Continuous(years)Survive at Day 28Non-survive at Day 28Total
Mean61.4 ± 17.363.7 ± 17.461.7 ± 17.3
Sex: Female, Male
Sex: Female, Male(Participants)Survive at Day 28Non-survive at Day 28Total
Female16922311923
Male23184112729
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Survive at Day 28Non-survive at Day 28Total
Thai40106424652
Region of Enrollment
Region of Enrollment(participants)Survive at Day 28Non-survive at Day 28Total
Thailand40106424652
08

Study locations

9 sites
  • Department of Anesthesiology, Faculty of Medicine, Srinakarin hospital
    Khon Kaen, Khon Khon 40002, Thailand
  • Department of Anesthesiology
    Nagorn Nayok, Nakorn Nayok 26120, Thailand
  • Department of Surgery and Department of Anesthesiology
    Songkhla, Songkha 90110, Thailand
  • Department of Surgery and Department of Anesthesiology, Bangkok metropolitan medical college and Vajira hospital
    Bangkok, 10300, Thailand
  • Department of Anesthesiology, Faculty of Medicine, Chulalongkorn hospital
    Bangkok, 10400, Thailand
  • Department of Anesthesiology, Faculty of Medicine, Ramathibodi hospital
    Bangkok, 10400, Thailand
  • Department of Surgery, Pramongkudklao hospital
    Bangkok, 10400, Thailand
  • Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital
    Bangkok, 10700, Thailand
  • Department of Surgery, Faculty of Medicine, Maharaj Nakorn Chiang Mai hospital
    Chiang Mai, 50200, Thailand
09

References and documents

Individual participant data

Plan to share: Yes — All the data was managed by the the Medical Research Network of the Consortium of Thai Medical Schools (MedResNet)

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01354197
Lead sponsor
Royal College of Anesthesiologists of Thailand
Collaborators
Siriraj Hospital, Chulalongkorn University, Chiang Mai University, Prince of Songkla University, Khon Kaen University, Srinakharinwirot University, Royal Thai Army Medical Department, Bangkok Metropolitan Administration Medical College and Vajira Hospital, Ramathibodi Hospital
Responsible party
Sponsor
First posted
May 16, 2011
Start date
Apr 2011
Primary completion
Nov 2012
Completion
Jan 2013
Results posted
Mar 27, 2017
Last update
Mar 27, 2017

Study contacts

Suneerat Kongsayreepong, MD.FRCAT
study chair · Mahidol University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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