Cardiopulmonary Bypass and Inflammatory Response

Thoracic Surgery Clinical Trial

— CPB-I  

Official title:

Cardiopulmonary Bypass and Inflammatory Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167349
• Other study ID #: 0306088
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: April 14, 2011
• Start date: December 2003
• Est. completion date: January 2005

Study information

• Verified date: April 2011
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine if a difference exists in the inflammatory response which occurs related to coronary artery bypass graft (CABG)surgery performed on cardiopulmonary bypass as compared to CABG surgery performed off bypass at the University of Pittsburgh Medical Center.

Description:

Acute inflammatory response occurring in cardiopulmonary bypass (CPB) patients has been clearly associated with deleterious clinical outcomes. Increasing understanding of the pathophysiology of systemic inflammatory response syndrome (SIRS) following CPB has facilitated the development of strategies to attenuate the damaging effects of cytokine-induced inflammation. For any strategy to be tested, one needs to clearly define and understand the inflammatory response occurring with CPB. Although this has been extensively studied, there is wide variation in the reported time course and magnitude of this response. This variation is, in part, due to the heterogeneous nature of the patient population studied (variable severity of illnesses, ejection fractions, co-morbidities, etc.). Hence, in our study, we propose to study the inflammatory response occurring in patients undergoing coronary artery bypass graft (CABG) with and without the use of CPB in our institution, and to determine whether the severity of inflammatory response seen in CABG patients is associated with impairment of any specific clinical parameter in the immediate post-operative period (i.e., ventricular dysfunction, lung injury, bleeding, renal failure, etc).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients undergoing CABG and/or patients undergoing other procedures (i.e., valve surgery, myomectomy, etc.) in addition to coronary revascularization

• Age: 18 years up to and including 90 years

Exclusion Criteria:

• Patient is not scheduled to undergo CABG surgery

• Ejection Fraction £ 30%

• Chronic renal failure requiring hemodialysis

• Long-term steroid use prior to surgery

• HIV positive patients (HIV testing will not be required to rule out HIV)

• Status post organ transplantation or on immune modulating drugs

• Presence of severe sepsis in the past month prior to surgery

• Prisoners

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Thoracic Surgery

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rimmelé T, Venkataraman R, Madden NJ, Elder MM, Wei LM, Pellegrini RV, Kellum JA. Comparison of inflammatory response during on-pump and off-pump coronary artery bypass surgery. Int J Artif Organs. 2010 Mar;33(3):131-8. — View Citation