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

NCT ID: NCT00563030

Last Updated: 2009-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Granulocyte Immature Forms Inflammatory Response Syndrome, Systemic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients undergoing CABG with CPB

No interventions assigned to this group

2

Patients undergoing off-pump CABG

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Gdańsk

Principal Investigators

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Maciej M Kowalik, MD, PhD

Role: STUDY_DIRECTOR

Medical University of Gdańsk, Dept. of Cardiac Anesthesiology

Locations

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Medical University of Gdańsk, Dept. of Cardiac Anesthesiology

Gdansk, , Poland

Site Status

Countries

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Poland

References

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Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. doi: 10.1378/chest.101.6.1644.

Reference Type BACKGROUND
PMID: 1303622 (View on PubMed)

Santa Ursula Tolosa JA, Criado A, Garcia del Valle S, Pensado A, Barbolla L, Carmona Aurioles JA. [Changes in total and differential leukocyte counts during heart surgery with extracorporeal circulation]. Rev Esp Anestesiol Reanim. 1991 Mar-Apr;38(2):94-7. Spanish.

Reference Type BACKGROUND
PMID: 1876745 (View on PubMed)

Orr Y, Taylor JM, Bannon PG, Geczy C, Kritharides L. Circulating CD10-/CD16low neutrophils provide a quantitative index of active bone marrow neutrophil release. Br J Haematol. 2005 Nov;131(4):508-19. doi: 10.1111/j.1365-2141.2005.05794.x.

Reference Type BACKGROUND
PMID: 16281943 (View on PubMed)

Orr Y, Wilson DP, Taylor JM, Bannon PG, Geczy C, Davenport MP, Kritharides L. A kinetic model of bone marrow neutrophil production that characterizes late phenotypic maturation. Am J Physiol Regul Integr Comp Physiol. 2007 Apr;292(4):R1707-16. doi: 10.1152/ajpregu.00627.2006. Epub 2006 Dec 21.

Reference Type BACKGROUND
PMID: 17185405 (View on PubMed)

Related Links

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http://www.amg.gda.pl/uczelnia/informator/jednostka.php?id=327

home page of Dept. of Cardiac Anesthesiology, Medical University of Gdańsk

Other Identifiers

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AMG-NKEBN/272/2007

Identifier Type: -

Identifier Source: org_study_id

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