Clinical trial NCT00167349: Cardiopulmonary Bypass and Inflammatory Response
Official title: Cardiopulmonary Bypass and Inflammatory Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Cardiopulmonary Bypass
Keywords: cardiac surgery
cardiopulmonary bypass
cytokines
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CABG patients

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: John A Kellum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rimmele 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. doi: 10.1177/039139881003300301.