Heart; Dysfunction Postoperative, Cardiac SurgeryNCT01559870
Peri-operative Prediction of Prolonged Stay in the Cardiac Intensive Care Unit for Adult Cardiac Surgery
An observational study of Heart; Dysfunction Postoperative, Cardiac Surgery and Cytokine Release Syndrome, run by Thepakorn Sathitkarnmanee at 3 sites in Thailand.
Trial summary
The purpose of this study is to create a model using intra-operative modified SOFA score and peri-operative clinical factors to predict prolonged stay in the cardiac intensive care unit (CICU) for adult cardiac surgery with heart-lung machine Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart; Dysfunction Postoperative, Cardiac Surgery, Cytokine Release Syndrome
- How many people
- 164 participants
- Where
- 3 sitesThailand
- Study dates
- Aug 2011to Aug 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients who had undergone elective cardiac surgery with CPB
Who may be able to join
- adult patients who had undergone elective cardiac surgery with CPB
Who cannot join
- under 18 years of age
- needing emergency surgery
- needing intra-aortic balloon pump
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Queen Sirikit Heart Cenrter
Khon Kaen, Changwat Khon Kaen, 40002
Queen Sirikit Heart Center
Khon Kaen, Changwat Khon Kaen, 40002
Queen Sirikit Heart Center
Khon Kaen, 40002
About this study
Official title: Peri-operative Prediction of Prolonged Stay in the Cardiac Intensive Care Unit for Adult Cardiac Surgery With Cardiopulmonary Bypass
The purpose of this study is to create a model using intra-operative modified SOFA score and peri-operative clinical factors to predict prolonged stay in the cardiac intensive care unit (CICU) for adult cardiac surgery with heart-lung machine
Read the detailed description
Cardiac surgery using cardiopulmonary bypass (CPB) is commonly associated with a systemic inflammatory response that exacerbates peri-operative life-threatening complications and multiple organ dysfunction syndromes. These features can prolong the stay in the CICU. Many peri-operative clinical risk factors contribute to those adverse outcomes resulting in prolonged CICU stay. If the investigators can create a model to identify the effects of these intra-operative clinical risk factors to prolonged CICU stay
- Keywords
- cardiac surgery, cytokine, clinical scoring system, risk factor
- Medical subject headings
- Cytokine Release Syndrome
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 |
|---|---|---|
| patients with elective cardiac surgery | adult patients who had undergone elective cardiac surgery with CPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted odds ratio of peri-operative clinical risk factors in prolonged CICU patients
Blood samples were collected for cytokines investigation and leukocyte counts. Clinical scoring systems , major peri-operative clinical risk factors were calculated and recorded at each time point. Univariate odds ratio were calculated for each factors for prolonged CICU stay. Those significant factors were included in logistic regression model for analysis of adjusted odds ratios. Then, a model for prolonged CICU stay is constructed.
Measured: 24 hours after CPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionMar 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart; Dysfunction Postoperative, Cardiac SurgeryStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thepakorn Sathitkarnmanee
- Sponsor type
- University, hospital or other
- Collaborators
- Khon Kaen University
- Responsible party
- Sponsor-investigator, Thepakorn Sathitkarnmanee, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559870
- Sponsor's protocol ID
- HE541122
- Status last verified
- Mar 2012
- First submitted
- 13 Mar 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Prediction of Prolonged Stay in the Cardiac Intensive Care Unit for Adult Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT01559870
- Acronym / sponsor ID
- HE541122
- Keywords
- cardiac surgery, cytokine, clinical scoring system, risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Thepakorn SathitkarnmaneeUniversity, hospital or other
- Collaborators
- Khon Kaen University
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Mar 2012 (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.
The purpose of this study is to create a model using intra-operative modified SOFA score and peri-operative clinical factors to predict prolonged stay in the cardiac intensive care unit (CICU) for adult cardiac surgery with heart-lung machine
Detailed description
Cardiac surgery using cardiopulmonary bypass (CPB) is commonly associated with a systemic inflammatory response that exacerbates peri-operative life-threatening complications and multiple organ dysfunction syndromes. These features can prolong the stay in the CICU. Many peri-operative clinical risk factors contribute to those adverse outcomes resulting in prolonged CICU stay. If the investigators can create a model to identify the effects of these intra-operative clinical risk factors to prolonged CICU stay
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with elective cardiac surgery | – | –adult patients who had undergone elective cardiac surgery with CPB |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients who had undergone elective cardiac surgery with CPB
Key inclusion criteria (1 listed)
- adult patients who had undergone elective cardiac surgery with CPB
Key exclusion criteria (3 listed)
- under 18 years of age
- needing emergency surgery
- needing intra-aortic balloon pump
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
Adjusted odds ratio of peri-operative clinical risk factors in prolonged CICU patients
Time frame: 24 hours after CPB
Blood samples were collected for cytokines investigation and leukocyte counts. Clinical scoring systems , major peri-operative clinical risk factors were calculated and recorded at each time point. Univariate odds ratio were calculated for each factors for prolonged CICU stay. Those significant factors were included in logistic regression model for analysis of adjusted odds ratios. Then, a model for prolonged CICU stay is constructed.
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 14 Nov 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart; Dysfunction Postoperative, Cardiac Surgery and Cytokine Release Syndrome, run by Thepakorn Sathitkarnmanee at 3 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 3 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 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Adjusted odds ratio of peri-operative clinical risk factors in prolonged CICU patients (time frame: 24 hours after CPB). 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 14 Nov 2012.