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

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.

Study Overview

• Status: Completed
• Conditions: Cytokine Release Syndrome; Heart; Dysfunction Postoperative, 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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Queen Sirikit Heart Center of the Northeast, Khon Kaen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult patients who had undergone elective cardiac surgery with CPB

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patients with elective cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 h after CPB

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Investigators: Principal Investigator: Sirirat Tribuddharat, MD, Faculty Of Medicine, Khon Kaen University

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: May 4, 2011
• First Submitted That Met QC Criteria: May 11, 2011
• First Posted (Estimate): May 12, 2011

Study Record Updates

• Last Update Posted (Estimate): May 12, 2011
• Last Update Submitted That Met QC Criteria: May 11, 2011
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: cardiac surgery; cytokine; clinical scoring system
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Cytokine Release Syndrome
• Other Study ID Numbers: HE531033