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

Cytokine Release Syndrome Clinical Trial

Official title:

Prediction for Systemic Inflammation With Clinical Scoring Systems and Inflammatory Cytokine Levels in Adult Cardiac and Major Abdominal Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353157
• Other study ID #: HE531033
• Status: Completed
• Phase: N/A
• First received: May 4, 2011
• Last updated: May 11, 2011
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2010
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Thailand	Queen Sirikit Heart Center of the Northeast, Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No