Heart; Dysfunction Postoperative, Cardiac SurgeryNCT01353157
Study of the Clinical Scoring System and Cytokines for Prediction of Inflammatory Response in Major Surgery
An observational study of Heart; Dysfunction Postoperative, Cardiac Surgery and Cytokine Release Syndrome, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Cardiac surgery with cardiopulmonary bypass (CPB) and hepatic surgery are major operations, associated with a systemic inflammatory response syndrome. The aim of this study is to assess the effectiveness of clinical scoring systems and inflammatory cytokine levels for predicting systemic inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart; Dysfunction Postoperative, Cardiac Surgery, Cytokine Release Syndrome
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2010to Dec 2010
- 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 years and older
- 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
1 site in 1 country.
Thailand1 site
Queen Sirikit Heart Center of the Northeast, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002
About this study
Official title: Prediction for Systemic Inflammation With Clinical Scoring Systems and Inflammatory Cytokine Levels in Adult Cardiac and Major Abdominal Surgical Patients
Cardiac surgery with cardiopulmonary bypass (CPB) and hepatic surgery are major operations, associated with a systemic inflammatory response syndrome. The aim of this study is to assess the effectiveness of clinical scoring systems and inflammatory cytokine levels for predicting systemic inflammation. This correlation might identify peri-operative clinical outcomes, then forecast further systemic inflammation in cardiac and hepatic surgical patients.
Read the detailed description
Systemic inflammatory response syndrome (SIRS) is commonly found in most major surgery. Early detection of SIRS will lead to early treatment. Serum cytokines levels are reliable markers for SIRS detection but with high cost and inconvenience. Clinical Scoring Systems are commonly used for assessment of patients with SIRS. If they have good correlation with cytokine levels, they might be used to predict peri-operative clinical outcomes.
- Keywords
- cytokine, cardiac surgery, clinical scoring system
- 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of clinical scoring systems and inflammatory cytokine levels
Blood samples were collected sequentially at 0, 0.5, 4, 12, and 24 h after CPB for cytokines [Interleukin (IL)-6, IL-8, and IL-10] investigation and leukocyte counts. Clinical scoring systems [Acute Physiology and Chronic Health Evaluation (APACHE) II, Sequential Organ Failure Assessment (SOFA) and Multi-Organ Dysfunction (MOD)] were calculated and recorded at each time point. Correlations were assessed.
Measured: 24 h after CPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startMar 2010
- Primary completionOct 2010
- Study completionDec 2010
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Investigators
- Sirirat Tribuddharat, MD, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353157
- Sponsor's protocol ID
- HE531033
- Status last verified
- Feb 2010
- First submitted
- 4 May 2011
- Last updated
- 12 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction for Systemic Inflammation With Clinical Scoring Systems and Inflammatory Cytokine Levels in Adult Cardiac and Major Abdominal Surgical Patients
- ClinicalTrials.gov ID
- NCT01353157
- Acronym / sponsor ID
- HE531033
- Keywords
- cytokine, cardiac surgery, clinical scoring system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 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.
Cardiac surgery with cardiopulmonary bypass (CPB) and hepatic surgery are major operations, associated with a systemic inflammatory response syndrome. The aim of this study is to assess the effectiveness of clinical scoring systems and inflammatory cytokine levels for predicting systemic inflammation. This correlation might identify peri-operative clinical outcomes, then forecast further systemic inflammation in cardiac and hepatic surgical patients.
Detailed description
Systemic inflammatory response syndrome (SIRS) is commonly found in most major surgery. Early detection of SIRS will lead to early treatment. Serum cytokines levels are reliable markers for SIRS detection but with high cost and inconvenience. Clinical Scoring Systems are commonly used for assessment of patients with SIRS. If they have good correlation with cytokine levels, they might be used to predict peri-operative clinical outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with elective cardiac surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- 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
Correlation of clinical scoring systems and inflammatory cytokine levels
Time frame: 24 h after CPB
Blood samples were collected sequentially at 0, 0.5, 4, 12, and 24 h after CPB for cytokines [Interleukin (IL)-6, IL-8, and IL-10] investigation and leukocyte counts. Clinical scoring systems [Acute Physiology and Chronic Health Evaluation (APACHE) II, Sequential Organ Failure Assessment (SOFA) and Multi-Organ Dysfunction (MOD)] were calculated and recorded at each time point. Correlations were assessed.
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 12 May 2011.
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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
Khon Kaen University
1 site 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 Khon Kaen University at 1 site 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 12 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Correlation of clinical scoring systems and inflammatory cytokine levels (time frame: 24 h 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 12 May 2011; AzTrials last refreshed its copy on 7 Nov 2026.