ICU StayNCT02945358
Assessment of OHIR Score to Predict a Prolonged Intensive Care Unit Stay
An observational study of ICU Stay, run by Khon Kaen University at 2 sites in Thailand.
Trial summary
A prolonged stay in intensive care unit (ICU) after cardiac surgery with cardiopulmonary bypass increases not only cost of patient care but also morbidity and mortality of patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ICU Stay
- What is being tested?
- adult cardiac surgery with cardiopulmonary pump
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 2 sitesThailand
- Study dates
- Sep 2016to Feb 2017
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing open-heart surgery both CABG and valve surgery with cardiopulmonary pump
Who may be able to join
- patients aged 18-75 undergoing cardiac surgery, both CABG and valvular surgery, with the use of cardiopulmonary bypass.
Who cannot join
- patients having emergency surgery; receiving special devices such as intra-aortic balloon pump or extracorporeal membrane oxygenation.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Queen Sirikit Heart Center
Khon Kaen, Changwat Khon Kaen, 40002
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002
About this study
Official title: Assessment of OHIR Score to Predict a Prolonged Intensive Care Unit Stay for Adult Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
A prolonged stay in intensive care unit (ICU) after cardiac surgery with cardiopulmonary bypass increases not only cost of patient care but also morbidity and mortality of patients. The ability to predict which patient has the tendency to have a prolonged ICU stay would help in patient and resource management of the hospital. There are many predictive models aiming at identifying patient at risk of prolonged ICU stay after cardiac surgery with cardiopulmonary bypass but almost all involve the preoperative assessment for proper resource management with one model, Open-Heart Intraoperative Risk (OHIR) Scoring concerning intraoperative manipulatable risk factors to improve anesthetic care and patient outcome. The OHIR model comprises 6 risk factors, 5 of which can be managed intraoperatively, with total score of 7 and a score of ≥ 3 indicating a likely prolonged ICU stay. The objective of this study was to re-validate the performance of OHIR score in the recent context.
Read the detailed description
This will be a retrospective, observational, analytical study. The study protocol was approved by the Human Research Ethics Committee, Khon Kaen University (HE581287).
The investigators will review all eligible medical records at Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast, Khon Kaen University during January 2013 and December 2014. The extracted data consist of patient's clinical data and all risk factors in the OHIR score. The investigators will apply the OHIR scoring to the data to assess its performance. The investigators will use the same criteria for a prolonged ICU stay as in the previous study, i.e. a stay longer that the median.
- Conditions
- ICU Stay
- Being tested
- adult cardiac surgery with cardiopulmonary pump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adult cardiac surgery with cardiopulmonary pumpProcedure or surgery
Open-heart surgery both coronary artery bypass graft (CABG) and valve surgery
| Study group | Role | What they receive |
|---|---|---|
| Prolonged ICU stay | Group 1: adult cardiac surgery with cardiopulmonary pump with prolonged ICU stay Group 2: adult cardiac surgery with cardiopulmonary pump with non-prolonged ICU stay Receives: Procedure: adult cardiac surgery with cardiopulmonary pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive care stay
number of hours admitted in ICU
Measured: through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ICU StayStudies 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
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thepakorn Sathitkarnmanee, Khon Kaen University
- Investigators
- Sirirat Tribuddharat, MD, Principal investigator, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945358
- Sponsor's protocol ID
- HE581287
- Status last verified
- Feb 2017
- First submitted
- 24 Oct 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Williams TA, Ho KM, Dobb GJ, Finn JC, Knuiman M, Webb SA; Royal Perth Hospital ICU Data Linkage Group. Effect of length of stay in intensive care unit on hospital and long-term mortality of critically ill adult patients. Br J Anaesth. 2010 Apr;104(4):459-64. doi: 10.1093/bja/aeq025. Epub 2010 Feb 25.
PubMed 20185517Hein OV, Birnbaum J, Wernecke K, England M, Konertz W, Spies C. Prolonged intensive care unit stay in cardiac surgery: risk factors and long-term-survival. Ann Thorac Surg. 2006 Mar;81(3):880-5. doi: 10.1016/j.athoracsur.2005.09.077.
PubMed 16488688Nakasuji M, Matsushita M, Asada A. Risk factors for prolonged ICU stay in patients following coronary artery bypass grafting with a long duration of cardiopulmonary bypass. J Anesth. 2005;19(2):118-23. doi: 10.1007/s00540-005-0301-9.
PubMed 15875128Gruenberg DA, Shelton W, Rose SL, Rutter AE, Socaris S, McGee G. Factors influencing length of stay in the intensive care unit. Am J Crit Care. 2006 Sep;15(5):502-9.
PubMed 16926372Almashrafi A, Alsabti H, Mukaddirov M, Balan B, Aylin P. Factors associated with prolonged length of stay following cardiac surgery in a major referral hospital in Oman: a retrospective observational study. BMJ Open. 2016 Jun 8;6(6):e010764. doi: 10.1136/bmjopen-2015-010764.
PubMed 27279475Almashrafi A, Elmontsri M, Aylin P. Systematic review of factors influencing length of stay in ICU after adult cardiac surgery. BMC Health Serv Res. 2016 Jul 29;16:318. doi: 10.1186/s12913-016-1591-3.
PubMed 27473872Tribuddharat S, Sathitkarnmanee T, Ngamsangsirisup K, Charuluxananan S, Hurst CP, Silarat S, Lertmemongkolchai G. Development of an open-heart intraoperative risk scoring model for predicting a prolonged intensive care unit stay. Biomed Res Int. 2014;2014:158051. doi: 10.1155/2014/158051. Epub 2014 Apr 10.
PubMed 24818129
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of OHIR Score to Predict a Prolonged Intensive Care Unit Stay for Adult Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02945358
- Acronym / sponsor ID
- HE581287
- Conditions
- ICU Stay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 26 Oct 2016 (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.
A prolonged stay in intensive care unit (ICU) after cardiac surgery with cardiopulmonary bypass increases not only cost of patient care but also morbidity and mortality of patients. The ability to predict which patient has the tendency to have a prolonged ICU stay would help in patient and resource management of the hospital. There are many predictive models aiming at identifying patient at risk of prolonged ICU stay after cardiac surgery with cardiopulmonary bypass but almost all involve the preoperative assessment for proper resource management with one model, Open-Heart Intraoperative Risk (OHIR) Scoring concerning intraoperative manipulatable risk factors to improve anesthetic care and patient outcome. The OHIR model comprises 6 risk factors, 5 of which can be managed intraoperatively, with total score of 7 and a score of ≥ 3 indicating a likely prolonged ICU stay. The objective of this study was to re-validate the performance of OHIR score in the recent context.
Detailed description
This will be a retrospective, observational, analytical study. The study protocol was approved by the Human Research Ethics Committee, Khon Kaen University (HE581287).
The investigators will review all eligible medical records at Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast, Khon Kaen University during January 2013 and December 2014. The extracted data consist of patient's clinical data and all risk factors in the OHIR score. The investigators will apply the OHIR scoring to the data to assess its performance. The investigators will use the same criteria for a prolonged ICU stay as in the previous study, i.e. a stay longer that the median.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolonged ICU stay | – | Procedure: adult cardiac surgery with cardiopulmonary pumpGroup 1: adult cardiac surgery with cardiopulmonary pump with prolonged ICU stay Group 2: adult cardiac surgery with cardiopulmonary pump with non-prolonged ICU stay |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing open-heart surgery both CABG and valve surgery with cardiopulmonary pump
Key inclusion criteria (1 listed)
- patients aged 18-75 undergoing cardiac surgery, both CABG and valvular surgery, with the use of cardiopulmonary bypass.
Key exclusion criteria (1 listed)
- patients having emergency surgery; receiving special devices such as intra-aortic balloon pump or extracorporeal membrane oxygenation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adult cardiac surgery with cardiopulmonary pumpOpen-heart surgery both coronary artery bypass graft (CABG) and valve surgery | Procedure or surgery | Prolonged ICU stay |
Primary outcome
Intensive care stay
Time frame: through study completion, an average of 1 week
number of hours admitted in ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Results publication: PubMed 20185517Williams TA, Ho KM, Dobb GJ, Finn JC, Knuiman M, Webb SA; Royal Perth Hospital ICU Data Linkage Group. Effect of length of stay in intensive care unit on hospital and long-term mortality of critically ill adult patients. Br J Anaesth. 2010 Apr;104(4):459-64. doi: 10.1093/bja/aeq025. Epub 2010 Feb 25.
- Results publication: PubMed 16488688Hein OV, Birnbaum J, Wernecke K, England M, Konertz W, Spies C. Prolonged intensive care unit stay in cardiac surgery: risk factors and long-term-survival. Ann Thorac Surg. 2006 Mar;81(3):880-5. doi: 10.1016/j.athoracsur.2005.09.077.
- Results publication: PubMed 15875128Nakasuji M, Matsushita M, Asada A. Risk factors for prolonged ICU stay in patients following coronary artery bypass grafting with a long duration of cardiopulmonary bypass. J Anesth. 2005;19(2):118-23. doi: 10.1007/s00540-005-0301-9.
- Results publication: PubMed 16926372Gruenberg DA, Shelton W, Rose SL, Rutter AE, Socaris S, McGee G. Factors influencing length of stay in the intensive care unit. Am J Crit Care. 2006 Sep;15(5):502-9.
- Results publication: PubMed 27279475Almashrafi A, Alsabti H, Mukaddirov M, Balan B, Aylin P. Factors associated with prolonged length of stay following cardiac surgery in a major referral hospital in Oman: a retrospective observational study. BMJ Open. 2016 Jun 8;6(6):e010764. doi: 10.1136/bmjopen-2015-010764.
- Results publication: PubMed 27473872Almashrafi A, Elmontsri M, Aylin P. Systematic review of factors influencing length of stay in ICU after adult cardiac surgery. BMC Health Serv Res. 2016 Jul 29;16:318. doi: 10.1186/s12913-016-1591-3.
- Results publication: PubMed 24818129Tribuddharat S, Sathitkarnmanee T, Ngamsangsirisup K, Charuluxananan S, Hurst CP, Silarat S, Lertmemongkolchai G. Development of an open-heart intraoperative risk scoring model for predicting a prolonged intensive care unit stay. Biomed Res Int. 2014;2014:158051. doi: 10.1155/2014/158051. Epub 2014 Apr 10.
- Individual participant dataSharing planned: No
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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.
Sirirat Tribuddharat, MD principal investigator
Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
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 ICU Stay, run by Khon Kaen 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 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 3 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intensive care stay (time frame: through study completion, an average of 1 week). 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 NCT02945358, which also lists 7 linked publications.
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 3 Mar 2017.