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

Critical Illness Clinical Trial

— THAI-SICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01354197
• Other study ID #: 40-53-11
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2011
• Last updated: May 20, 2011
• Start date: April 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2011
• Source: Royal College of Anesthesiologists of Thailand
• Contact: Channarong Chokbumrungsuk
• Phone: +6629510352
• Email: channarong[@]crcn.in.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial Summary

• Overall treatment outcomes of University base SICU

• Incidence of adverse events in SICU

• Factor associated to adverse events in SICU

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All SICU admission patients

Exclusion Criteria:

• Age < 18 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adverse Reaction to Drug
• Complications of Surgical and Medical Care: General Terms
• Critical Illness
• Drug-Related Side Effects and Adverse Reactions
• Sequelae of External Causes of Morbidity and Mortality

Locations

Country	Name	City	State
Thailand	Department of Anesthesiology, Faculty of Medicine, Chulalongkorn hospital	Bangkok
Thailand	Department of Anesthesiology, Faculty of Medicine, Ramathibodi hospital	Bangkok
Thailand	Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital	Bangkok
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 Surgery, Faculty of Medicine, Maharaj Nakorn Chiang Mai hospital	Chiang Mai
Thailand	Department of Anesthesiology, Faculty of Medicine, Srinakarin hospital	Khon Kaen	Khon Khon
Thailand	Department of Anesthesiology	Nagorn Nayok	Nakorn Nayok
Thailand	Department of Surgery and Department of Anesthesiology	Songkhla	Songkha

Sponsors (9)

Lead Sponsor	Collaborator
Royal College of Anesthesiologists of Thailand	Bangkok Metropolitan Administration Medical College and Vajira Hospital, Chiang Mai University, Chulalongkorn University, Khon Kaen University, Mahidol University, Prince of Songkla University, Royal Thai Army Medical Department, Srinakharinwirot University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall mortality	Mortality in overall causes	28 days	Yes
Secondary	Readmission to ICU	Readmission to ICU within 3 days after discharage from ICU	within 3 days	Yes
Secondary	ICU complications	Complication included : Sepsis, Acute kidney injury, Delirium, Unexpected cardiac arrest, Acute myocardial infarction, Acute respiratory failure, Gastrointestinal complication, Stroke	Upto 28 days	Yes