Complications of Surgical and Medical Care: General TermsTHAI-SICUNCT01354197
The Thai Surgical Intensive Care Study (Thai-SICU Study)
An observational study of Complications of Surgical and Medical Care: General Terms and Adverse Reaction to Drug, run by Royal College of Anesthesiologists of Thailand at 9 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complications of Surgical and Medical Care: General Terms, Adverse Reaction to Drug, Sequelae of External Causes of Morbidity and Mortality
- How many people
- 4,652 participants
- Where
- 9 sitesThailand
- Study dates
- Apr 2011to Jan 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All SICU admission patients
Who may be able to join
- All SICU admission patients
Who cannot join
- Age < 18 years
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Thailand9 sites
Department of Surgery and Department of Anesthesiology, Bangkok metropolitan medical college and Vajira hospital
Bangkok, Bangkok, 10300
Department of Anesthesiology, Faculty of Medicine, Chulalongkorn hospital
Bangkok, Bangkok, 10400
Department of Anesthesiology, Faculty of Medicine, Ramathibodi hospital
Bangkok, Bangkok, 10400
Department of Surgery, Pramongkudklao hospital
Bangkok, Bangkok, 10400
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital
Bangkok, Bangkok, 10700
Department of Surgery, Faculty of Medicine, Maharaj Nakorn Chiang Mai hospital
Chiang Mai, Chiang Mai, 50200
Department of Anesthesiology, Faculty of Medicine, Srinakarin hospital
Khon Kaen, Khon Khon, 40002
Department of Anesthesiology
Nakhon Nayok, Nakorn Nayok, 26120
Department of Surgery and Department of Anesthesiology
Songkhla, Songkha, 90110
About this study
Official title: Multicenter Study of Outcome and Adverse Events in Surgical Intensive Care Unit of Thai University Hospital
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.
Read the 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
- Conditions
- Complications of Surgical and Medical Care: General Terms, Adverse Reaction to Drug, Sequelae of External Causes of Morbidity and Mortality, Critical Illness
- Keywords
- Adverse events, Mortality, Readmission, Surgical intensive care unit
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All ICU admission patients | All ICU admission to surgical intensive care unit at cohort time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Mortality
Number of Participants who Did Not Survive up to 28 days after surgical ICU admission
Measured: 28 days
Secondary outcomes (1)
Readmission to ICU
Number of Participants with Readmission to ICU up to 3 days (72 hours) after discharge from ICU
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Complications of Surgical and Medical Care: General TermsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Anesthesiologists of Thailand
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Suneerat Kongsayreepong, MD.FRCAT, Study chair, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354197
- Sponsor's protocol ID
- 40-53-11
- Acronym
- THAI-SICU
- Status last verified
- Feb 2017
- First submitted
- 13 May 2011
- Last updated
- 27 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All the data was managed by the the Medical Research Network of the Consortium of Thai Medical Schools (MedResNet)
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Outcome and Adverse Events in Surgical Intensive Care Unit of Thai University Hospital
- ClinicalTrials.gov ID
- NCT01354197
- Acronym / sponsor ID
- THAI-SICU / 40-53-11
- Conditions
- Complications of Surgical and Medical Care: General Terms, Adverse Reaction to Drug, Sequelae of External Causes of Morbidity and Mortality, Critical Illness
- Keywords
- Adverse events, Mortality, Readmission, Surgical intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,652 participants (actual)
- Lead sponsor
- Royal College of Anesthesiologists of ThailandUniversity, hospital or other
- Collaborators
- 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
- Study start
- Apr 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 May 2011 (estimated)
- Results
- Posted 27 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All ICU admission patients | – | –All ICU admission to surgical intensive care unit at cohort time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All SICU admission patients
Key inclusion criteria (1 listed)
- All SICU admission patients
Key exclusion criteria (1 listed)
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Mortality
Time frame: 28 days
Number of Participants who Did Not Survive up to 28 days after surgical ICU admission
1 secondary outcome
Readmission to ICU
Time frame: 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All the data was managed by the the Medical Research Network of the Consortium of Thai Medical Schools (MedResNet)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suneerat Kongsayreepong, MD.FRCAT study chair
Mahidol University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications of Surgical and Medical Care: General Terms and Adverse Reaction to Drug, run by Royal College of Anesthesiologists of Thailand at 9 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.