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

November 2, 2009 updated by: Medical University of Gdansk

Comparison of Granulocyte Subsets in Peripheral Blood After Coronary Bypass Grafting Operations With and Without Use of Cardiopulmonary Bypass

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.

Study Overview

Status

Completed

Conditions

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:

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

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Poland
- - Gdańsk, Poland, 80-211
    - Medical University of Gdańsk, Dept. of Cardiac Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Patients undergoing CABG with CPB
2 Patients undergoing off-pump CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage of immature forms of neutrophils in peripheral blood Time Frame: first 48 hours after operation	first 48 hours after operation

Secondary Outcome Measures

Outcome Measure	Time Frame
clinical signs of SIRS: heart rate, temperature, pCO2, respiratory rate (as applicable), total white blood cells Time Frame: first 48 hours after operation	first 48 hours after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Investigators

Study Director: Maciej M Kowalik, MD, PhD, Medical University of Gdańsk, Dept. of Cardiac Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

November 23, 2007

First Submitted That Met QC Criteria