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

Completed

• Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery; Cytokine Release Syndrome

• Registration Number: NCT01353157
• Lead Sponsor: Khon Kaen University

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.

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 Timeline

• Status Verified: 2010-02
• Study Start: 2010-03
• Primary Completion: 2010-10
• Study Completion: 2010-12
• Study First Submitted: 2011-05-04
• Study First Submitted QC: 2011-05-11
• Last Update Submitted: 2011-05-11
• Study First Posted: 2011-05-12
• Last Update Posted: 2011-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of clinical scoring systems and inflammatory cytokine levels	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.

Trial Locations

Locations (1)

Queen Sirikit Heart Center of the Northeast, Khon Kaen University; 🇹🇭 Khon Kaen, Thailand