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

NCT01353157 | Completed

• 1 other identifier: HE531033
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery; Cytokine Release Syndrome

Keywords

cytokine; cardiac surgery; clinical scoring system

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

patients with elective cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients who had undergone elective cardiac surgery with CPB

You may qualify if:

• adult patients who had undergone elective cardiac surgery with CPB

You may not qualify if:

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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Queen Sirikit Heart Center of the Northeast, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood taken from arterial line

MeSH Terms

Conditions

Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Sirirat Tribuddharat, MD

  Faculty of Medicine, Khon Kaen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 12, 2011
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 12, 2011

Record last verified: 2010-02

Locations

TH (1)