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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Royal College of Anesthesiologists of Thailand.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Mahidol University
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
Information provided by:
Royal College of Anesthesiologists of Thailand
ClinicalTrials.gov Identifier:
NCT01354197
First received: May 13, 2011
Last updated: May 20, 2011
Last verified: May 2011
  Purpose
  • Overall treatment outcomes of University base SICU
  • Incidence of adverse events in SICU
  • Factor associated to 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 ] [ Designated as safety issue: Yes ]
    Mortality in overall causes


Secondary Outcome Measures:
  • Readmission to ICU [ Time Frame: within 3 days ] [ Designated as safety issue: Yes ]
    Readmission to ICU within 3 days after discharage from ICU

  • ICU complications [ Time Frame: Upto 28 days ] [ Designated as safety issue: Yes ]
    Complication included : Sepsis, Acute kidney injury, Delirium, Unexpected cardiac arrest, Acute myocardial infarction, Acute respiratory failure, Gastrointestinal complication, Stroke


Estimated Enrollment: 5000
Study Start Date: April 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: March 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:

Adverse events included

  • Sepsis
  • Respiratory failure
  • Acute kidney injury
  • Readmission to ICU
  • Myocardial infarction
  • Delirium
  • Abdominal hypertension
  • Drug error
  • Unexpected cardiac arrest Factors associated
  • Type of ICU
  • Sedation and analgesics
  • Nutritional status and delivery
  • Smoking
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Mahidol University
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
Investigators
Study Chair: Suneerat Kongsayreepong, MD.FRCAT Mahidol University
  More Information

Responsible Party: Clinical Research Collaboration Network (CRCN), Clinical Research Collaboration Network Foundation
ClinicalTrials.gov Identifier: NCT01354197     History of Changes
Other Study ID Numbers: 40-53-11 
Study First Received: May 13, 2011
Last Updated: May 20, 2011
Health Authority: Thailand: Ethical Committee

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 December 08, 2016