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Bands in Peripheral Blood After Coronary Artery Bypass Grafting With and Without Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Information provided by:
Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT00563030
First received: November 23, 2007
Last updated: November 2, 2009
Last verified: November 2009
History of Changes
  Purpose

Coronary artery bypass graft (CABG) surgery is associated with reperfusion syndrome and activation of inflammatory reaction (SIRS). These are more exaggerated when cardiopulmonary bypass (CPB) is used.

The aim of the study is to compare signs of SIRS (heart rate, tachypnea or hypocarbia, leukocytosis, hyperpyrexia or hypothermia) and the granulocytes subsets in peripheral blood from patients who underwent CABG surgery with or without use of CPB.

The researchers expect significant differences in SIRS criteria between both groups. If the differences will occur significant, the parameter may be used as candidate variable for a complications prediction model after CABG surgery.


Condition
Granulocyte Immature Forms
Inflammatory Response Syndrome, Systemic

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Granulocyte Subsets in Peripheral Blood After Coronary Bypass Grafting Operations With and Without Use of Cardiopulmonary Bypass

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • percentage of immature forms of neutrophils in peripheral blood [ Time Frame: first 48 hours after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical signs of SIRS: heart rate, temperature, pCO2, respiratory rate (as applicable), total white blood cells [ Time Frame: first 48 hours after operation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood on EDTA vials for automatical morphology analysis and manual blood-smear preparation.


Enrollment: 44
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients undergoing CABG with CPB
2
Patients undergoing off-pump CABG

Detailed Description:

Patients fulfilling inclusion criteria will be asked to sign the consent to participate in the study, the day before operation after routine preoperative anesthesiological evaluation. If included into the study they will be assigned to one of the two study groups - off-pump CABG, or CABG with CPB.

After arrival into the operating theatre 4.5 ml blood will be obtained into EDTA vials from a peripheral venous canula, placed previously for routine anesthesiologic management.

Additional blood samples will be obtained 3, 6, 12, 24 and 48 hours after the operation. Each vial will be immediately labeled with an identification number and submitted into the laboratory, where smear with May-Grunwald-Giemsa staining will be prepared. The smear will be panoptical examined for 400 consecutive leucocytes and assigned to one of the following lines: neutrophils, eosinophils, basophils, monocytes and lymphocytes. Neutrophils will be further divided into: segments, bands, metamyelocytes, myelocytes, promyelocytes, myeloblasts.

The laboratory staff will be blinded for type of operation. Differences in subsets of granulocytes between groups and timepoints wil be analysed as means by appropriate parametric or nonparametric statistical tests.

The SIRS criteria will be refered to:

  1. Intraoperative variables: number of distal anastomoses, time of aorta/artery clamping, time of intraoperative hypotension, suction pump use, serum lactates;
  2. Postoperative variables: serum CRP, blood products transfusion, chest tube drainage.
  Eligibility

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

Patients qualified for elective CABG with or without cardiopulmonary bypass. If possible, patient will be matched by age, sex, left ventricle ejection fraction, number of grafts, and major comorbidities (diabetes mellitus, arteriosclerosis).

Criteria

Inclusion Criteria:

  • Elective or urgent CABG with CPB or without (off-pump CABG)
  • Signed informed consent

Exclusion Criteria:

  • Denied consent
  • Signs of infection and/or inflammation (at least 2/4 SIRS criteria)
  • Emergency operation
  • Organ failure/dysfunction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563030

Locations
Poland
Medical University of Gdańsk, Dept. of Cardiac Anesthesiology
Gdańsk, Poland, 80-211
Sponsors and Collaborators
Medical University of Gdansk
Investigators
Study Director: Maciej M Kowalik, MD, PhD Medical University of Gdańsk, Dept. of Cardiac Anesthesiology
  More Information

Publications:

Responsible Party: Maciej M. Kowalik MD, PhD, Medical University of Gdańsk
ClinicalTrials.gov Identifier: NCT00563030     History of Changes
Other Study ID Numbers: AMG-NKEBN/272/2007
Study First Received: November 23, 2007
Last Updated: November 2, 2009
Health Authority: Poland: Ministry of Health

Keywords provided by Medical University of Gdansk:
Cardiopulmonary bypass
Neutrophils
Coronary artery bypass graft surgery

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on May 19, 2013