NCT00167349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

April 15, 2011

Status Verified

April 1, 2011

Enrollment Period

1.1 years

First QC Date

September 9, 2005

Last Update Submit

April 14, 2011

Conditions

Thoracic SurgeryCardiopulmonary Bypass

Keywords

cardiac surgerycardiopulmonary bypasscytokines

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CABG patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

  • 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.

    PMID: 20383854RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and serum

Study Officials

  • John A Kellum, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

December 1, 2003

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

April 15, 2011

Record last verified: 2011-04

Locations

US(1)