Trial Outcomes & Findings for The Thai Surgical Intensive Care Study (Thai-SICU Study) (NCT NCT01354197)

NCT ID: NCT01354197

Last Updated: 2017-03-27

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 4652 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2017-03-27

Participant Flow

Participant milestones

Measure	All ICU Admission Patients All ICU admission to surgical intensive care unit at cohort time
Overall Study STARTED	4652
Overall Study COMPLETED	4652
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Survive at Day 28 n=4010 Participants The patients who survived at 28 days after surgical ICU admission.	Non-survive at Day 28 n=642 Participants The patients who non-survived at 28 days after surgical ICU admission.	Total n=4652 Participants Total of all reporting groups
Age, Continuous	61.4 years STANDARD_DEVIATION 17.3 • n=5 Participants	63.7 years STANDARD_DEVIATION 17.4 • n=7 Participants	61.7 years STANDARD_DEVIATION 17.3 • n=5 Participants
Sex: Female, Male Female	1692 Participants n=5 Participants	231 Participants n=7 Participants	1923 Participants n=5 Participants
Sex: Female, Male Male	2318 Participants n=5 Participants	411 Participants n=7 Participants	2729 Participants n=5 Participants
Race/Ethnicity, Customized Thai	4010 participants n=5 Participants	642 participants n=7 Participants	4652 participants n=5 Participants
Region of Enrollment Thailand	4010 participants n=5 Participants	642 participants n=7 Participants	4652 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

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

Outcome measures

Measure	All ICU Admission Patients n=4652 Participants All ICU admission to surgical intensive care unit at cohort time
Overall Mortality	642 participants

SECONDARY outcome

Timeframe: 3 days

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

Outcome measures

Measure	All ICU Admission Patients n=4652 Participants All ICU admission to surgical intensive care unit at cohort time
Readmission to ICU	144 participants

Adverse Events

Survive at Day 28

Serious events: 1070 serious events

Other events: 253 other events

Deaths: 0 deaths

Non-survive at Day 28

Serious events: 519 serious events

Other events: 90 other events

Deaths: 0 deaths

Serious adverse events

Measure	Survive at Day 28 n=4010 participants at risk Number of participants who survive at day 28	Non-survive at Day 28 n=642 participants at risk Number of participants who Did Not survive at day 28
Infections and infestations Sepsis	15.1% 607/4010 • Number of events 607 • Up to 28 days after surgical ICU admission 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	46.7% 300/642 • Number of events 300 • Up to 28 days after surgical ICU admission 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
Cardiac disorders Cardiac arrest	0.42% 17/4010 • Number of events 17 • Up to 28 days after surgical ICU admission 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	32.6% 209/642 • Number of events 209 • Up to 28 days after surgical ICU admission 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
Respiratory, thoracic and mediastinal disorders Acute lung injury/ Acute respiratory distress syndrome	3.0% 119/4010 • Number of events 119 • Up to 28 days after surgical ICU admission 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	18.5% 119/642 • Number of events 119 • Up to 28 days after surgical ICU admission 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
Respiratory, thoracic and mediastinal disorders Pulmonary emboli	0.07% 3/4010 • Number of events 3 • Up to 28 days after surgical ICU admission 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	0.16% 1/642 • Number of events 1 • Up to 28 days after surgical ICU admission 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
Cardiac disorders New arrhythmia	4.6% 184/4010 • Number of events 184 • Up to 28 days after surgical ICU admission 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	16.0% 103/642 • Number of events 103 • Up to 28 days after surgical ICU admission 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
Nervous system disorders New stroke	0.22% 9/4010 • Number of events 9 • Up to 28 days after surgical ICU admission 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	0.31% 2/642 • Number of events 2 • Up to 28 days after surgical ICU admission 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
Nervous system disorders Seizure	0.65% 26/4010 • Number of events 26 • Up to 28 days after surgical ICU admission 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	3.0% 19/642 • Number of events 19 • Up to 28 days after surgical ICU admission 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
Cardiac disorders Myocardial infarction	1.2% 47/4010 • Number of events 47 • Up to 28 days after surgical ICU admission 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	3.0% 19/642 • Number of events 19 • Up to 28 days after surgical ICU admission 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
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.82% 33/4010 • Number of events 33 • Up to 28 days after surgical ICU admission 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	3.4% 22/642 • Number of events 22 • Up to 28 days after surgical ICU admission 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
Renal and urinary disorders Acute kidney injury	12.2% 491/4010 • Number of events 491 • Up to 28 days after surgical ICU admission 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	46.0% 295/642 • Number of events 295 • Up to 28 days after surgical ICU admission 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
Gastrointestinal disorders Intra-abdominal hypertension	1.3% 54/4010 • Number of events 54 • Up to 28 days after surgical ICU admission 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	2.6% 17/642 • Number of events 17 • Up to 28 days after surgical ICU admission 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

Other adverse events

Measure	Survive at Day 28 n=4010 participants at risk Number of participants who survive at day 28	Non-survive at Day 28 n=642 participants at risk Number of participants who Did Not survive at day 28
Nervous system disorders Delirium	2.9% 117/4010 • Number of events 117 • Up to 28 days after surgical ICU admission 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	7.2% 46/642 • Number of events 46 • Up to 28 days after surgical ICU admission 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
Respiratory, thoracic and mediastinal disorders Reintubation within 72 hours	2.8% 112/4010 • Number of events 112 • Up to 28 days after surgical ICU admission 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	4.5% 29/642 • Number of events 29 • Up to 28 days after surgical ICU admission 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
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.35% 14/4010 • Number of events 14 • Up to 28 days after surgical ICU admission 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	1.7% 11/642 • Number of events 11 • Up to 28 days after surgical ICU admission 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
Respiratory, thoracic and mediastinal disorders Unplanned extubation	1.0% 41/4010 • Number of events 41 • Up to 28 days after surgical ICU admission 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	2.5% 16/642 • Number of events 16 • Up to 28 days after surgical ICU admission 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
Surgical and medical procedures Self reported medication error	0.17% 7/4010 • Number of events 7 • Up to 28 days after surgical ICU admission 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	0.47% 3/642 • Number of events 3 • Up to 28 days after surgical ICU admission 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
Respiratory, thoracic and mediastinal disorders Pulmonary aspiration	0.05% 2/4010 • Number of events 2 • Up to 28 days after surgical ICU admission 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	0.16% 1/642 • Number of events 1 • Up to 28 days after surgical ICU admission 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
Vascular disorders Symptomatic deep venous thrombosis	0.25% 10/4010 • Number of events 10 • Up to 28 days after surgical ICU admission 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	0.62% 4/642 • Number of events 4 • Up to 28 days after surgical ICU admission 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

Additional Information

Kaweesak Chittawatanarat

Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand

Phone: 053-935533

Email: kchittaw@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place