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

Completed

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

• Registration Number: NCT01354197
• Lead Sponsor: Royal College of Anesthesiologists of Thailand

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.

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Primary Completion: 2012-11
• Study Completion: 2013-01
• Results First Submitted: 2016-10-04
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-05
• Last Update Submitted: 2017-02-05
• Results First Posted: 2017-03-27
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4652

Inclusion Criteria

• All SICU admission patients

Exclusion Criteria

• Age < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Mortality	28 days	Number of Participants who Did Not Survive up to 28 days after surgical ICU admission

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Department of Anesthesiology, Faculty of Medicine, Ramathibodi hospital; 🇹🇭 Bangkok, Thailand

Department of Surgery and Department of Anesthesiology; 🇹🇭 Songkhla, Songkha, Thailand

Department of Anesthesiology, Faculty of Medicine, Chulalongkorn hospital; 🇹🇭 Bangkok, Thailand

Department of Anesthesiology, Faculty of Medicine, Srinakarin hospital; 🇹🇭 Khon Kaen, Khon Khon, Thailand

Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Department of Surgery, Faculty of Medicine, Maharaj Nakorn Chiang Mai hospital; 🇹🇭 Chiang Mai, Thailand

Department of Surgery and Department of Anesthesiology, Bangkok metropolitan medical college and Vajira hospital; 🇹🇭 Bangkok, Thailand

Department of Surgery, Pramongkudklao hospital; 🇹🇭 Bangkok, Thailand

Department of Anesthesiology; 🇹🇭 Nagorn Nayok, Nakorn Nayok, Thailand