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Study of the Clinical Scoring System and Cytokines for Prediction of Inflammatory Response in Major Surgery

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ClinicalTrials.gov Identifier: NCT01353157
Recruitment Status : Completed
First Posted : May 12, 2011
Last Update Posted : May 12, 2011
Information provided by:

Study Description
Brief 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. This correlation might identify peri-operative clinical outcomes, then forecast further systemic inflammation in cardiac and hepatic surgical patients.

Condition or disease
Heart; Dysfunction Postoperative, Cardiac Surgery Cytokine Release Syndrome

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

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prediction for Systemic Inflammation With Clinical Scoring Systems and Inflammatory Cytokine Levels in Adult Cardiac and Major Abdominal Surgical Patients
Study Start Date : March 2010
Primary Completion Date : October 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Groups and Cohorts

patients with elective cardiac surgery

Outcome Measures

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples Without DNA
whole blood taken from arterial line

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patients who had undergone elective cardiac surgery with CPB

Inclusion Criteria:

  • adult patients who had undergone elective cardiac surgery with CPB

Exclusion Criteria:

  • under 18 years of age
  • needing emergency surgery
  • needing intra-aortic balloon pump
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353157

Queen Sirikit Heart Center of the Northeast, Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Principal Investigator: Sirirat Tribuddharat, MD Faculty of Medicine, Khon Kaen University
More Information

Responsible Party: Sirirat Tribuddharat, Faculty of Medicine, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01353157     History of Changes
Other Study ID Numbers: HE531033
First Posted: May 12, 2011    Key Record Dates
Last Update Posted: May 12, 2011
Last Verified: February 2010

Keywords provided by Khon Kaen University:
cardiac surgery
clinical scoring system