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

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: NCT01354197
Recruitment Status : Completed
First Posted : May 16, 2011
Results First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
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
Information provided by (Responsible Party):
Royal College of Anesthesiologists of Thailand

Study Description
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Brief 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.

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

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
Study Design
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Study Type : Observational
Actual Enrollment : 4652 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Study of Outcome and Adverse Events in Surgical Intensive Care Unit of Thai University Hospital
Study Start Date : April 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : January 2013
Groups and Cohorts
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Group/Cohort
All ICU admission patients
All ICU admission to surgical intensive care unit at cohort time


Outcome Measures
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Primary Outcome Measures :
  1. Overall Mortality [ Time Frame: 28 days ]
    Number of Participants who Did Not Survive up to 28 days after surgical ICU admission


Secondary Outcome Measures :
  1. Readmission to ICU [ Time Frame: 3 days ]
    Number of Participants with Readmission to ICU up to 3 days (72 hours) after discharge from ICU


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All SICU admission patients
Criteria

Inclusion Criteria:

  • All SICU admission patients

Exclusion Criteria:

  • Age < 18 years
Contacts and Locations
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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): NCT01354197


Locations
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Thailand
Department of Anesthesiology, Faculty of Medicine, Srinakarin hospital
Khon Kaen, Khon Khon, Thailand, 40002
Department of Anesthesiology
Nagorn Nayok, Nakorn Nayok, Thailand, 26120
Department of Surgery and Department of Anesthesiology
Songkhla, Songkha, Thailand, 90110
Department of Surgery and Department of Anesthesiology, Bangkok metropolitan medical college and Vajira hospital
Bangkok, Thailand, 10300
Department of Anesthesiology, Faculty of Medicine, Chulalongkorn hospital
Bangkok, Thailand, 10400
Department of Anesthesiology, Faculty of Medicine, Ramathibodi hospital
Bangkok, Thailand, 10400
Department of Surgery, Pramongkudklao hospital
Bangkok, Thailand, 10400
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital
Bangkok, Thailand, 10700
Department of Surgery, Faculty of Medicine, Maharaj Nakorn Chiang Mai hospital
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Royal College of Anesthesiologists of Thailand
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
Investigators
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Study Chair: Suneerat Kongsayreepong, MD.FRCAT Mahidol University
More Information
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Responsible Party: Royal College of Anesthesiologists of Thailand
ClinicalTrials.gov Identifier: NCT01354197    
Other Study ID Numbers: 40-53-11
First Posted: May 16, 2011    Key Record Dates
Results First Posted: March 27, 2017
Last Update Posted: March 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All the data was managed by the the Medical Research Network of the Consortium of Thai Medical Schools (MedResNet)
Keywords provided by Royal College of Anesthesiologists of Thailand:
Adverse events
Mortality
Readmission
Surgical intensive care unit
Additional relevant MeSH terms:
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Critical Illness
Drug-Related Side Effects and Adverse Reactions
Disease Attributes
Pathologic Processes
Chemically-Induced Disorders