ComplicationNCT01361477
Data Registry of Intensive Care Unit (ICU) Siamitra and Intensive Care Unit (ICU) Salad-Samung
An observational study of Complication, run by Mahidol University at 2 sites in Thailand.
Trial summary
As a general surgical intensive care units of the biggest tertiary referral university of Thailand with more than 1,000 admissions/year, recently, more complicated perioperative care surgical patients were accepted with high complications, morbidities, mortality and resource utilization. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Complication
- How many people
- 2,000 participants
- Where
- 2 sitesThailand
- Study dates
- May 2011to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult (> 18 years), admitting to ICU Siamitra and ICU Salad-Samung
Who may be able to join
- Age > 18 years
- Surgical patients
Who cannot join
- Patient undergoing cardiothoracic surgery, traumatic surgery, neurosurgery
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
ICU Siamitra and ICU Salad-Samung, Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
Suneerat Kongsereepong, MD, +66818427419, suneerat.kon@mahidol.ac.th
Annop Piriyapatsom, MD, annop.pir@mahidol.ac.th
- Recruiting
ICU Siamitra and ICU Salad-Samung, Siriraj Hospital
Bangkoknoi, Bangkok, 10700
Suneerat Kongsereepong, MD, +661-8427419, suneerat.kon@mahidol.ac.th
Onuma Chaiwat, MD, onuma27@hotmail.com
About this study
Official title: Data Registry of ICU Siamitra and ICU Salad-Samung
As a general surgical intensive care units of the biggest tertiary referral university of Thailand with more than 1,000 admissions/year, recently, more complicated perioperative care surgical patients were accepted with high complications, morbidities, mortality and resource utilization. Good data registration was needed to provide information for quality improvement and resource allocation. This prospective observational (crosssectional) study was designed to register patient > 18 years who will be admitted to these ICUs to explore the adequacy of these ICUs services, resource utilization (ICU length of stay and ventilator day), ICU complications, adverse outcome /ICU readmission within 72 hours after discharging from ICU. In addition, severe hemodynamic, respiratory, or neurological disturbance or complication intra and early postoperative (within 7 days after operation) that lead to ICU admission eg, intraoperative hypotension, intraoperative cardiac arrest, perioperative pulmonary aspirtaion will also be studied.
Read the detailed description
This prospective obseverational study wae ans will be done in all surgical patient (age . 18 yeras) admitted to the general surgical ICU (ICU Siammitra and ICU Salad-sumang) of the Department of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol UNiversity, Bangkok, Thailand. After approval by the IRB of Siriaj Hospital, all information of the patients admiited to the ICUs were carefully recorded included patient demographic data, comorbidities, type of anesthesia, type of surgery, complication associated with anesthesia and surgery, type of ICU admission and course in ICU including outcome as Iresouce utilization (cost in ICU, ventilator day, ICU and hosital length of stay. Morbidity occcuring in ICU, 28 and 90 days mortality also recorded.
- Conditions
- Complication
- Keywords
- General surgical ICU, ICU Siamitra, ICU Salad-Samung, Data registry, ICU refusal, ICU complications, ICU resource utilization, Adverse events, ICU readmission, intraoperative hypotension, intraoperative cardiac arrest
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 |
|---|---|---|
| patient | 1. Prolonged ICU stay 2. Unplanned ICU admission 3. Complication/adversel during ICU admission 4. Result of intraoperative complications and admission to ICU 5 Result of early postoperative (within 7 days) and ICU admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged ICU stay
Incidence and factors associated with prolonged ICU stay
Measured: 9 years
Secondary outcomes (4)
ICU complication, resource utilization and adverse events/ICU readmission within 72 hours after discharging from ICU
ICU complication, resource utilization and adverse events/ICU admission within 72 hours after discharging from ICU
Measured: 9 years
Unplanned ICU admission
All unplanned ICU Admission (from OR and from floor)
Measured: 9 years
outcome of complications occurring intraoperative and admitting to ICU
all complication including: intraoperative cardiac arrest, hypotension
Measured: 9 years
sepsis and septic shock on ICU admission
incidence, clinical course and outcome of surgical septic shock admitting to ICU
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ComplicationStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suneerat Kongsayreepong, MD, Mahidol University
- Investigators
- Suneerat Kongsereepong, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361477
- Sponsor's protocol ID
- Si227/2011
- Status last verified
- Oct 2023
- First submitted
- 25 May 2011
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Capuzzo M, Moreno RP, Alvisi R. Admission and discharge of critically ill patients. Curr Opin Crit Care. 2010 Oct;16(5):499-504. doi: 10.1097/MCC.0b013e32833cb874.
PubMed 20644469
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Registry of ICU Siamitra and ICU Salad-Samung
- ClinicalTrials.gov ID
- NCT01361477
- Acronym / sponsor ID
- Si227/2011
- Conditions
- Complication
- Keywords
- General surgical ICU, ICU Siamitra, ICU Salad-Samung, Data registry, ICU refusal, ICU complications, ICU resource utilization, Adverse events
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2011 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 26 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As a general surgical intensive care units of the biggest tertiary referral university of Thailand with more than 1,000 admissions/year, recently, more complicated perioperative care surgical patients were accepted with high complications, morbidities, mortality and resource utilization. Good data registration was needed to provide information for quality improvement and resource allocation. This prospective observational (crosssectional) study was designed to register patient > 18 years who will be admitted to these ICUs to explore the adequacy of these ICUs services, resource utilization (ICU length of stay and ventilator day), ICU complications, adverse outcome /ICU readmission within 72 hours after discharging from ICU. In addition, severe hemodynamic, respiratory, or neurological disturbance or complication intra and early postoperative (within 7 days after operation) that lead to ICU admission eg, intraoperative hypotension, intraoperative cardiac arrest, perioperative pulmonary aspirtaion will also be studied.
Detailed description
This prospective obseverational study wae ans will be done in all surgical patient (age . 18 yeras) admitted to the general surgical ICU (ICU Siammitra and ICU Salad-sumang) of the Department of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol UNiversity, Bangkok, Thailand. After approval by the IRB of Siriaj Hospital, all information of the patients admiited to the ICUs were carefully recorded included patient demographic data, comorbidities, type of anesthesia, type of surgery, complication associated with anesthesia and surgery, type of ICU admission and course in ICU including outcome as Iresouce utilization (cost in ICU, ventilator day, ICU and hosital length of stay. Morbidity occcuring in ICU, 28 and 90 days mortality also recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | – | –1. Prolonged ICU stay 2. Unplanned ICU admission 3. Complication/adversel during ICU admission 4. Result of intraoperative complications and admission to ICU 5 Result of early postoperative (within 7 days) and ICU admission |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult (> 18 years), admitting to ICU Siamitra and ICU Salad-Samung
Key inclusion criteria (2 listed)
- Age > 18 years
- Surgical patients
Key exclusion criteria (1 listed)
- Patient undergoing cardiothoracic surgery, traumatic surgery, neurosurgery
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
Prolonged ICU stay
Time frame: 9 years
Incidence and factors associated with prolonged ICU stay
4 secondary outcomes
ICU complication, resource utilization and adverse events/ICU readmission within 72 hours after discharging from ICU
Time frame: 9 years
Unplanned ICU admission
Time frame: 9 years
outcome of complications occurring intraoperative and admitting to ICU
Time frame: 9 years
sepsis and septic shock on ICU admission
Time frame: 9 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Results publication: PubMed 20644469Capuzzo M, Moreno RP, Alvisi R. Admission and discharge of critically ill patients. Curr Opin Crit Care. 2010 Oct;16(5):499-504. doi: 10.1097/MCC.0b013e32833cb874.
- Individual participant dataSharing planned: Undecided
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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 Kongsereepong, MD principal investigator
Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication, run by Mahidol University at 2 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 2 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: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suneerat Kongsayreepong, MD (+661-8427419, suneerat.kon@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged ICU stay (time frame: 9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01361477, which also lists 1 linked publication.
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 1 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.