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

• Sponsor: Royal College of Anesthesiologists of Thailand (Other)
• Overall Status: Completed
• CT.gov ID: NCT01354197
• Collaborator: Siriraj Hospital (Other), Chulalongkorn University (Other), Chiang Mai University (Other), Prince of Songkla University (Other), Khon Kaen University (Other), Srinakharinwirot University (Other), Royal Thai Army Medical Department (Other), Bangkok Metropolitan Administration Medical College and Vajira Hospital (Other), Ramathibodi Hospital (Other)
• Enrollment: 4,652
• Locations: 9
• Duration (Months): 21.1
• Patients Per Site: 516.9
• Patients Per Site Per Month: 24.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complications of Surgical and Medical Care: General Terms; Adverse Reaction to Drug; Sequelae of External Causes of Morbidity and Mortality; Critical Illness

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 Design

• Study Type: Observational
• Actual Enrollment: 4652 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Multicenter Study of Outcome and Adverse Events in Surgical Intensive Care Unit of Thai University Hospital
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
All ICU admission patients All ICU admission to surgical intensive care unit at cohort time

Outcome Measures

Primary Outcome Measures

1. Overall Mortality [28 days]

   Number of Participants who Did Not Survive up to 28 days after surgical ICU admission

Secondary Outcome Measures

1. Readmission to ICU [3 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All SICU admission patients

Exclusion Criteria:

• Age < 18 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology, Faculty of Medicine, Srinakarin hospital	Khon Kaen	Khon Khon	Thailand	40002
2	Department of Anesthesiology	Nagorn Nayok	Nakorn Nayok	Thailand	26120
3	Department of Surgery and Department of Anesthesiology	Songkhla	Songkha	Thailand	90110
4	Department of Surgery and Department of Anesthesiology, Bangkok metropolitan medical college and Vajira hospital	Bangkok		Thailand	10300
5	Department of Anesthesiology, Faculty of Medicine, Chulalongkorn hospital	Bangkok		Thailand	10400
6	Department of Anesthesiology, Faculty of Medicine, Ramathibodi hospital	Bangkok		Thailand	10400
7	Department of Surgery, Pramongkudklao hospital	Bangkok		Thailand	10400
8	Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital	Bangkok		Thailand	10700
9	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Royal College of Anesthesiologists of Thailand
• ClinicalTrials.gov Identifier: NCT01354197
• Other Study ID Numbers: 40-53-11
• First Posted: May 16, 2011
• Last Update Posted: Mar 27, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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

Study Results

Participant Flow

Arm/Group Title	All ICU Admission Patients
Arm/Group Description	All ICU admission to surgical intensive care unit at cohort time
Period Title: Overall Study
STARTED	4652
COMPLETED	4652
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Survive at Day 28	Non-survive at Day 28	Total
Arm/Group Description	The patients who survived at 28 days after surgical ICU admission.	The patients who non-survived at 28 days after surgical ICU admission.	Total of all reporting groups
Overall Participants	4010	642	4652
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.4 (17.3)	63.7 (17.4)	61.7 (17.3)
Sex: Female, Male (Count of Participants)
Female	1692 42.2%	231 36%	1923 41.3%
Male	2318 57.8%	411 64%	2729 58.7%
Race/Ethnicity, Customized (participants) [Number]
Thai	4010 100%	642 100%	4652 100%
Region of Enrollment (participants) [Number]
Thailand	4010 100%	642 100%	4652 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All ICU Admission Patients
Arm/Group Description	All ICU admission to surgical intensive care unit at cohort time
Measure Participants	4652
Number [participants]	642 16%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All ICU Admission Patients
Arm/Group Description	All ICU admission to surgical intensive care unit at cohort time
Measure Participants	4652
Number [participants]	144 3.6%

Adverse Events

Time Frame	Up to 28 days after surgical ICU admission
Adverse Event Reporting Description	The adverse events were collected up to 28 days in all participants who survive at day 28 and did not survive at day 28 after surgical ICU admission
Arm/Group Title	Survive at Day 28		Non-survive at Day 28
Arm/Group Description	Number of participants who survive at day 28		Number of participants who Did Not survive at day 28
All Cause Mortality
	Survive at Day 28		Non-survive at Day 28
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Survive at Day 28		Non-survive at Day 28
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1070/4010 (26.7%)		519/642 (80.8%)
Cardiac disorders
Cardiac arrest	17/4010 (0.4%)	17	209/642 (32.6%)	209
New arrhythmia	184/4010 (4.6%)	184	103/642 (16%)	103
Myocardial infarction	47/4010 (1.2%)	47	19/642 (3%)	19
Gastrointestinal disorders
Upper gastrointestinal hemorrhage	33/4010 (0.8%)	33	22/642 (3.4%)	22
Intra-abdominal hypertension	54/4010 (1.3%)	54	17/642 (2.6%)	17
Infections and infestations
Sepsis	607/4010 (15.1%)	607	300/642 (46.7%)	300
Nervous system disorders
New stroke	9/4010 (0.2%)	9	2/642 (0.3%)	2
Seizure	26/4010 (0.6%)	26	19/642 (3%)	19
Renal and urinary disorders
Acute kidney injury	491/4010 (12.2%)	491	295/642 (46%)	295
Respiratory, thoracic and mediastinal disorders
Acute lung injury/ Acute respiratory distress syndrome	119/4010 (3%)	119	119/642 (18.5%)	119
Pulmonary emboli	3/4010 (0.1%)	3	1/642 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Survive at Day 28		Non-survive at Day 28
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	253/4010 (6.3%)		90/642 (14%)
Nervous system disorders
Delirium	117/4010 (2.9%)	117	46/642 (7.2%)	46
Respiratory, thoracic and mediastinal disorders
Reintubation within 72 hours	112/4010 (2.8%)	112	29/642 (4.5%)	29
Pneumothorax	14/4010 (0.3%)	14	11/642 (1.7%)	11
Unplanned extubation	41/4010 (1%)	41	16/642 (2.5%)	16
Pulmonary aspiration	2/4010 (0%)	2	1/642 (0.2%)	1
Surgical and medical procedures
Self reported medication error	7/4010 (0.2%)	7	3/642 (0.5%)	3
Vascular disorders
Symptomatic deep venous thrombosis	10/4010 (0.2%)	10	4/642 (0.6%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.