Coronary DiseaseNCT02213939
Clinical Impact of Cytokine in Cardiac Surgery
An observational study of Coronary Disease, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
Cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma and the use of the cardiopulmonary bypass (CPB). Activation of inflammatory cascades can cause a systemic inflammatory response syndrome (SIRS) which is associated with increased morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Jul 2018
- 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 receiving surgical myocardila revascularization
Who may be able to join
- • Elective myocardial revascularization
Who cannot join
- Emergency procedures
- Declined informed consent
- Body mass index < 18
- Age < 18 years
- Pregnant women
- Receiving chemotherapy
Show all 11Show fewer
- Diagnosed with any disease state (e.g., AIDS) that has produced leukopenia
- Receiving antileukocyte drugs
- Receiving TNF-α Blockers
- Receiving immunosuppressive drugs or hormone therapy (e.g. tamoxifen)
- CRP > 5 mg/dl
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne; Department of Cardiothoracic Surgery
Cologne, 50379
Antje C Deppe, MD, 0049 221 478 32453, antje-christin.deppe@uk-koeln.de
Yeong-Hoon Choi, MD, 0049221 478 32452, yeong-hoon.choi@uk-koeln.de
About this study
Official title: Removal of Cytokine on Cardiopulmonary Bypass With CytoSorb® Compared to on- and Off-pump Myocardial Revascularization
Cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma and the use of the cardiopulmonary bypass (CPB). Activation of inflammatory cascades can cause a systemic inflammatory response syndrome (SIRS) which is associated with increased morbidity and mortality. Therefore, strategies to reduce the inflammatory response have a potential benefit for cardiac surgery patients.
The clinical benefit of reducing proinflammatory cytokines such as IL-6, Il-8 and TNF-a with the use of a cytokine adsorbing circuit (Cytosorb) during CBP remains unclear. Therefore, the investigators conduct this prospective, observational pilot study to determine the clinical impact of the use of a cytokine adsorbing circuit during CBP.
Read the detailed description
Patients, who have an elective myocardial revascularization and give there written consent will be enrolled to the study. Demographic, intraoperative, and postoperative data will be collected prospectively. Furthermore, blood samples (1. before induction of anaesthesia 2. at the end of CPB 3. 6 hours after surgery 4. 24 hours after surgery 5. 3-5 days after surgery) will be analyzed.
- Conditions
- Coronary Disease
- Keywords
- Myocardial revascularization, Cytosorb, Inflammatory response, Cardiopulmonary bypass
- Medical subject headings
- Coronary Disease
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 |
|---|---|---|
| CPB + Cytosorb | On pump myocardial revascularization with the use of the cytokine adsorbing circuit (Cytosorb) | |
| CPB / Control | Controll group; on pump myocardial revascularization | |
| OPCAB / Control | Controll Group; off-pump myocardial revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the inflammatory response
Il-6; Il-8; TNF-a; C3/C4-complement Leucocytes CRP
Measured: Change from Baseline in cytokine level direct after surgery, 6 and 24 hours after surgery; 5. postoperative day
Secondary outcomes (5)
Length of ICU and hospital stay
Length of ICU and hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
Length of ventilation
Length of ventilation (hours)
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
Length of catecholamine therapy
Length of catecholamine therapy
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
kidney injury
kidney injury defined as an increase in SCr by ≥1.0 mg/dl (≥26.5 μmol/l) after surgery ; or Increase in SCr to ≥1.5 times baseline, or Urine volume < 0.5 ml/kg/h for 6 hours.
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
MACCE (mortality; myocardial infarction; cerebrovascular accident)
Mortality measured as any kind of death and myocardial death Myocardial Infarction measured with ECG; CK-MB, cTnT Cerebrovascular accident verified with abnormal cerebral CT scan
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antje-Christin Deppe, University Hospital of Cologne
- Investigators
- Antje C Deppe, MD, Principal investigator, University Hospital of Cologne; Department of Cardiothoracic Surgery;
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213939
- Sponsor's protocol ID
- Cytosorb2014
- Status last verified
- Jul 2017
- First submitted
- 4 Aug 2014
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal of Cytokine on Cardiopulmonary Bypass With CytoSorb® Compared to on- and Off-pump Myocardial Revascularization
- ClinicalTrials.gov ID
- NCT02213939
- Acronym / sponsor ID
- Cytosorb2014
- Conditions
- Coronary Disease
- Keywords
- Myocardial revascularization, Cytosorb, Inflammatory response, Cardiopulmonary bypass
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 12 Aug 2014 (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.
Cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma and the use of the cardiopulmonary bypass (CPB). Activation of inflammatory cascades can cause a systemic inflammatory response syndrome (SIRS) which is associated with increased morbidity and mortality. Therefore, strategies to reduce the inflammatory response have a potential benefit for cardiac surgery patients.
The clinical benefit of reducing proinflammatory cytokines such as IL-6, Il-8 and TNF-a with the use of a cytokine adsorbing circuit (Cytosorb) during CBP remains unclear. Therefore, the investigators conduct this prospective, observational pilot study to determine the clinical impact of the use of a cytokine adsorbing circuit during CBP.
Detailed description
Patients, who have an elective myocardial revascularization and give there written consent will be enrolled to the study. Demographic, intraoperative, and postoperative data will be collected prospectively. Furthermore, blood samples (1. before induction of anaesthesia 2. at the end of CPB 3. 6 hours after surgery 4. 24 hours after surgery 5. 3-5 days after surgery) will be analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPB + Cytosorb | – | –On pump myocardial revascularization with the use of the cytokine adsorbing circuit (Cytosorb) |
| CPB / Control | – | –Controll group; on pump myocardial revascularization |
| OPCAB / Control | – | –Controll Group; off-pump myocardial revascularization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving surgical myocardila revascularization
Key inclusion criteria (1 listed)
- • Elective myocardial revascularization
Key exclusion criteria (11 listed)
- Emergency procedures
- Declined informed consent
- Body mass index < 18
- Age < 18 years
- Pregnant women
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
Evolution of the inflammatory response
Time frame: Change from Baseline in cytokine level direct after surgery, 6 and 24 hours after surgery; 5. postoperative day
Il-6; Il-8; TNF-a; C3/C4-complement Leucocytes CRP
5 secondary outcomes
Length of ICU and hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Length of ventilation
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Length of catecholamine therapy
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
kidney injury
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
MACCE (mortality; myocardial infarction; cerebrovascular accident)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
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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.
University Hospital of Cologne; Department of Cardiothoracic Surgery
Cologne, Germany
Antje C Deppe, MD principal investigator
University Hospital of Cologne; Department of Cardiothoracic Surgery;
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 Coronary Disease, run by University Hospital of Cologne at 1 site in Germany.
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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Jul 2017. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the inflammatory response (time frame: Change from Baseline in cytokine level direct after surgery, 6 and 24 hours after surgery; 5. postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2017.