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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01354197
First received: May 13, 2011
Last updated: February 5, 2017
Last verified: February 2017
  Purpose
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
Complications of Surgical and Medical Care: General Terms Adverse Reaction to Drug Sequelae of External Causes of Morbidity and Mortality Critical Illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Study of Outcome and Adverse Events in Surgical Intensive Care Unit of Thai University Hospital

Further study details as provided by Royal College of Anesthesiologists of Thailand:

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


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


Enrollment: 4652
Study Start Date: April 2011
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
All ICU admission patients
All ICU admission to surgical intensive care unit at cohort time

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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354197

Locations
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
Study Chair: Suneerat Kongsayreepong, MD.FRCAT Mahidol University
  More Information

Responsible Party: Royal College of Anesthesiologists of Thailand
ClinicalTrials.gov Identifier: NCT01354197     History of Changes
Other Study ID Numbers: 40-53-11
Study First Received: May 13, 2011
Results First Received: October 4, 2016
Last Updated: February 5, 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:
Critical Illness
Drug-Related Side Effects and Adverse Reactions
Disease Attributes
Pathologic Processes
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 21, 2017