Adverse Reaction to Drug, Complications of Surgical and Medical Care: General Terms, Critical Illness, Sequelae of External Causes of Morbidity and Mortality
Conditions
Keywords
Adverse events, Mortality, Readmission, Surgical intensive care unit
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
Interventions
None listed
Sponsors
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
Royal College of Anesthesiologists of Thailand
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All SICU admission patients
Exclusion criteria
* Age \< 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Mortality | 28 days | Number of Participants who Did Not Survive up to 28 days after surgical ICU admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Readmission to ICU | 3 days | Number of Participants with Readmission to ICU up to 3 days (72 hours) after discharge from ICU |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Survive at Day 28 The patients who survived at 28 days after surgical ICU admission. | 4,010 |
| Non-survive at Day 28 The patients who non-survived at 28 days after surgical ICU admission. | 642 |
| Total | 4,652 |
Baseline characteristics
| Characteristic | Non-survive at Day 28 | Total | Survive at Day 28 |
|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 17.4 | 61.7 years STANDARD_DEVIATION 17.3 | 61.4 years STANDARD_DEVIATION 17.3 |
| Race/Ethnicity, Customized Thai | 642 participants | 4652 participants | 4010 participants |
| Region of Enrollment Thailand | 642 participants | 4652 participants | 4010 participants |
| Sex: Female, Male Female | 231 Participants | 1923 Participants | 1692 Participants |
| Sex: Female, Male Male | 411 Participants | 2729 Participants | 2318 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 253 / 4,010 | 90 / 642 |
| serious Total, serious adverse events | 1,070 / 4,010 | 519 / 642 |
Outcome results
Primary
Overall Mortality
Number of Participants who Did Not Survive up to 28 days after surgical ICU admission
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All ICU Admission Patients | Overall Mortality | 642 participants |
Secondary
Readmission to ICU
Number of Participants with Readmission to ICU up to 3 days (72 hours) after discharge from ICU
Time frame: 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All ICU Admission Patients | Readmission to ICU | 144 participants |