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

This study has been completed.
Sponsor:
Information provided by:
Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01353157
First received: May 4, 2011
Last updated: May 11, 2011
Last verified: February 2010
  Purpose

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
Heart; Dysfunction Postoperative, Cardiac Surgery
Cytokine Release Syndrome

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Correlation of clinical scoring systems and inflammatory cytokine levels [ Time Frame: 24 h after CPB ] [ Designated as safety issue: No ]
    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


Enrollment: 20
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with elective cardiac surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

adult patients who had undergone elective cardiac surgery with CPB

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353157

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

No publications provided

Responsible Party: Sirirat Tribuddharat, Faculty of Medicine, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01353157     History of Changes
Other Study ID Numbers: HE531033
Study First Received: May 4, 2011
Last Updated: May 11, 2011
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

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

ClinicalTrials.gov processed this record on September 18, 2014