Granulocyte Immature FormsNCT00563030
Bands in Peripheral Blood After Coronary Artery Bypass Grafting With and Without Cardiopulmonary Bypass
An observational study of Granulocyte Immature Forms and Inflammatory Response Syndrome, Systemic, run by Medical University of Gdansk at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Granulocyte Immature Forms, Inflammatory Response Syndrome, Systemic
- How many people
- 44 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2007to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Elective or urgent CABG with CPB or without (off-pump CABG)
- Signed informed consent
Who cannot join
- Denied consent
- Signs of infection and/or inflammation (at least 2/4 SIRS criteria)
- Emergency operation
- Organ failure/dysfunction
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Gdańsk, Dept. of Cardiac Anesthesiology
Gdansk, 80-211
About this study
Official title: 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.
Read the 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.
- Keywords
- Cardiopulmonary bypass, Neutrophils, Coronary artery bypass graft surgery
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients undergoing CABG with CPB | |
| 2 | Patients undergoing off-pump CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of immature forms of neutrophils in peripheral blood
Measured: first 48 hours after operation
Secondary outcomes (1)
clinical signs of SIRS: heart rate, temperature, pCO2, respiratory rate (as applicable), total white blood cells
Measured: first 48 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Granulocyte Immature FormsStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Investigators
- Maciej M Kowalik, MD, PhD, Study director, Medical University of Gdańsk, Dept. of Cardiac Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563030
- Sponsor's protocol ID
- AMG-NKEBN/272/2007
- Status last verified
- Nov 2009
- First submitted
- 23 Nov 2007
- Last updated
- 3 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 1303622Santa 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.
PubMed 1876745Orr 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.
PubMed 16281943Orr 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.
PubMed 17185405
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Granulocyte Subsets in Peripheral Blood After Coronary Bypass Grafting Operations With and Without Use of Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00563030
- Acronym / sponsor ID
- AMG-NKEBN/272/2007
- Keywords
- Cardiopulmonary bypass, Neutrophils, Coronary artery bypass graft surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients undergoing CABG with CPB |
| 2 | – | –Patients undergoing off-pump CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Elective or urgent CABG with CPB or without (off-pump CABG)
- Signed informed consent
Key exclusion criteria (4 listed)
- Denied consent
- Signs of infection and/or inflammation (at least 2/4 SIRS criteria)
- Emergency operation
- Organ failure/dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
percentage of immature forms of neutrophils in peripheral blood
Time frame: first 48 hours after operation
1 secondary outcome
clinical signs of SIRS: heart rate, temperature, pCO2, respiratory rate (as applicable), total white blood cells
Time frame: first 48 hours after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2009.
- Background: PubMed 1303622Bone 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.
- Background: PubMed 1876745Santa 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.
- Background: PubMed 16281943Orr 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.
- Background: PubMed 17185405Orr 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.
- home page of Dept. of Cardiac Anesthesiology, Medical University of GdańskLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maciej M Kowalik, MD, PhD study director
Medical University of Gdańsk, Dept. of Cardiac Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Granulocyte Immature Forms and Inflammatory Response Syndrome, Systemic, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of immature forms of neutrophils in peripheral blood (time frame: first 48 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00563030, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2009.