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

Multicenter Study of Outcome and Adverse Events in Surgical Intensive Care Unit of Thai University Hospital

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 4652

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All SICU admission patients

Description

Inclusion Criteria:

• All SICU admission patients

Exclusion Criteria:

• Age < 18 years

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All ICU admission patients; All ICU admission to surgical intensive care unit at cohort time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Mortality	Number of Participants who Did Not Survive up to 28 days after surgical ICU admission	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission to ICU	Number of Participants with Readmission to ICU up to 3 days (72 hours) after discharge from ICU	3 days

Collaborators and Investigators

• Sponsor: Royal College of Anesthesiologists of Thailand
• Collaborators: Chulalongkorn University; Khon Kaen University; Ramathibodi Hospital; Prince of Songkla University; Chiang Mai University; Bangkok Metropolitan Administration Medical College and Vajira Hospital; Srinakharinwirot University; Siriraj Hospital; Royal Thai Army Medical Department
• Investigators: Study Chair: Suneerat Kongsayreepong, MD.FRCAT, Mahidol University

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: May 13, 2011
• First Submitted That Met QC Criteria: May 13, 2011
• First Posted (Estimate): May 16, 2011

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: February 5, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Mortality; Adverse events; Readmission; Surgical intensive care unit
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Disease Attributes; Critical Illness; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 40-53-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All the data was managed by the the Medical Research Network of the Consortium of Thai Medical Schools (MedResNet)