Thoracic SurgeryCPB-INCT00167349
Cardiopulmonary Bypass and Inflammatory Response
An observational study of Thoracic Surgery and Cardiopulmonary Bypass, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Thoracic Surgery, Cardiopulmonary Bypass
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Jan 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CABG patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
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.
Read the 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).
- Conditions
- Thoracic Surgery, Cardiopulmonary Bypass
- Keywords
- cardiac surgery, cardiopulmonary bypass, cytokines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- John A Kellum, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167349
- Sponsor's protocol ID
- 0306088
- Acronym
- CPB-I
- Status last verified
- Apr 2011
- First submitted
- 9 Sep 2005
- Last updated
- 15 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20383854
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Bypass and Inflammatory Response
- ClinicalTrials.gov ID
- NCT00167349
- Acronym / sponsor ID
- CPB-I / 0306088
- Conditions
- Thoracic Surgery, Cardiopulmonary Bypass
- Keywords
- cardiac surgery, cardiopulmonary bypass, cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CABG patients
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2011.
- Results publication: PubMed 20383854Rimmele 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Kellum, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery and Cardiopulmonary Bypass, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00167349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2011.