Cardiopulmonary Bypass and Inflammatory Response (CPB-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00167349
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 15, 2011
Information provided by:
University of Pittsburgh

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.

Condition or disease
Thoracic Surgery Cardiopulmonary Bypass

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).

Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiopulmonary Bypass and Inflammatory Response
Study Start Date : December 2003
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Biospecimen Retention:   Samples Without DNA
plasma and serum

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CABG patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00167349

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: John A Kellum, MD University of Pittsburgh

Publications of Results:
Responsible Party: John A. Kellum, MD, University of Pittsburgh School of Medicine Identifier: NCT00167349     History of Changes
Other Study ID Numbers: 0306088
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: April 2011

Keywords provided by University of Pittsburgh:
cardiac surgery
cardiopulmonary bypass