Bands in Peripheral Blood After Coronary Artery Bypass Grafting With and Without Cardiopulmonary Bypass
|ClinicalTrials.gov Identifier: NCT00563030|
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : November 3, 2009
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 or disease|
|Granulocyte Immature Forms Inflammatory Response Syndrome, Systemic|
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|
|Actual Enrollment :||44 participants|
|Observational Model:||Case Control|
|Official Title:||Comparison of Granulocyte Subsets in Peripheral Blood After Coronary Bypass Grafting Operations With and Without Use of Cardiopulmonary Bypass|
|Study Start Date :||December 2007|
|Primary Completion Date :||April 2009|
|Study Completion Date :||May 2009|
Patients undergoing CABG with CPB
Patients undergoing off-pump CABG
- percentage of immature forms of neutrophils in peripheral blood [ Time Frame: first 48 hours after operation ]
- clinical signs of SIRS: heart rate, temperature, pCO2, respiratory rate (as applicable), total white blood cells [ Time Frame: first 48 hours after operation ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563030
|Medical University of Gdańsk, Dept. of Cardiac Anesthesiology|
|Gdańsk, Poland, 80-211|
|Study Director:||Maciej M Kowalik, MD, PhD||Medical University of Gdańsk, Dept. of Cardiac Anesthesiology|