Cardiopulmonary Bypass and Inflammatory Response (CPB-I)

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00167349
First received: September 9, 2005
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

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
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).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

CABG patients

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167349

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

Publications:
Responsible Party: John A. Kellum, MD, University of Pittsburgh School of Medicine
ClinicalTrials.gov Identifier: NCT00167349     History of Changes
Other Study ID Numbers: 0306088
Study First Received: September 9, 2005
Last Updated: April 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
cardiac surgery
cardiopulmonary bypass
cytokines

ClinicalTrials.gov processed this record on April 23, 2014