Clinical trial NCT00563030: Bands in Peripheral Blood After Coronary Artery Bypass Grafting With and Without Cardiopulmonary Bypass
Official title: Comparison of Granulocyte Subsets in Peripheral Blood After Coronary Bypass Grafting Operations With and Without Use of Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Granulocyte Immature Forms
Inflammatory Response Syndrome, Systemic
Keywords: Cardiopulmonary bypass
Neutrophils
Coronary artery bypass graft surgery
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2007-11-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

Brief summary: 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: 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 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

Primary outcomes:
measure: percentage of immature forms of neutrophils in peripheral blood
timeFrame: first 48 hours after operation
Secondary outcomes:
measure: clinical signs of SIRS: heart rate, temperature, pCO2, respiratory rate (as applicable), total white blood cells
timeFrame: first 48 hours after operation
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk, Dept. of Cardiac Anesthesiology
Study officials:
affiliation: Medical University of Gdańsk, Dept. of Cardiac Anesthesiology
name: Maciej M Kowalik, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.