This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Cardiopulmonary Bypass and Inflammatory Response (CPB-I)

This study has been completed.
Information provided by:
University of Pittsburgh Identifier:
First received: September 9, 2005
Last updated: April 14, 2011
Last verified: April 2011
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.

Thoracic Surgery Cardiopulmonary Bypass

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiopulmonary Bypass and Inflammatory Response

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples Without DNA
plasma and serum

Enrollment: 37
Study Start Date: December 2003
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: John A. Kellum, MD, University of Pittsburgh School of Medicine Identifier: NCT00167349     History of Changes
Other Study ID Numbers: 0306088
Study First Received: September 9, 2005
Last Updated: April 14, 2011

Keywords provided by University of Pittsburgh:
cardiac surgery
cardiopulmonary bypass
cytokines processed this record on August 16, 2017