Elective Cardiac Surgical Interventions
Conditions
Brief summary
Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response induced by extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit, endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation, ischemia-reperfusion injury of myocardium) factors. Monocytes are important players in systemic inflammation and the main producers of pro- and antiinflammatory cytokines. Monocytes activated by the extracorporeal circuit lead to a dysregulation of inflammatory homeostasis, increased levels of proinflammatory plasma mediators such as TNF-a, IL-1β, IL-6 and IL-18 are joined by antiinflammatory cytokines such as IL-10. This strong inflammatory response induces post surgical monocyte immunosuppression which is indicated by an impaired production of ex vivo LPS induced TNF-a production. Also malfunction of the peripheral circulation with increased lactate levels, pronounced fluid accumulation, increased need of vasopressors and cerebral dysfunction are observed. All of these factors may delay weaning from the ventilator, recovery of organ functions and discharge from ICU. Thus measures to decrease the inflammatory process have the potential to improve the perioperative course. Use of cytokine adsorbing circuit during CBP has an effect on circulation cytokine levels for the first 36 hours after surgery and induces a decreased inflammatory response for up to 3 days post surgery.
Detailed description
Patients, who have an elective cardiac surgical intervention with an expected CBP duration \>120 minutes (e.g.: valve surgery, coronary artery bypass graft (CABG), combined procedures) will be enrolled to the study after given informed consent. Patients, who decline will be asked to collect their secondary outcome data to create a real - life group and increase the number of patients in the control group. In this real - life group no additional blood samples will be taken.
Interventions
DEVICECytoSorb
Sponsors
CytoSorbents, Inc
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* elective cardiac surgical intervention with an expected CBP duration \>120 minutes
Exclusion criteria
* Emergency procedures * Heart transplantation * Elective left ventricular assist device (LVAD) implantation * Pulmonary thromendarterectomy * Declined informed consent * Serum creatinine \> 2mg/dl * Body mass index \< 18 * Age \< 18 years * Pregnant woman * Receiving chemotherapy or diagnosed with any disease state (e.g., AIDS) that has produced leukopenia * Receiving antileukocyte drugs * Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab) * CRP \> 2mg/dl * History of Stroke * Bilirubin \>2mg/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IL-6 | 1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CytoSorb For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1. | 19 |
| Control No filter will be installed on the CPB machine. | 18 |
| Total | 37 |
Baseline characteristics
| Characteristic | CytoSorb | Control | Total |
|---|---|---|---|
| Age, Continuous | 64 years | 69 years | 67 years |
| Gender Female | 7 Participants | 4 Participants | 11 Participants |
| Gender Male | 12 Participants | 14 Participants | 26 Participants |
| Region of Enrollment Austria | 19 participants | 18 participants | 37 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 |
Outcome results
Primary
IL-6
Time frame: 1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CytoSorb | IL-6 | 2 hours after CPB | 120.8 pg/ml |
| CytoSorb | IL-6 | 24 hours after CPB | 111.6 pg/ml |
| CytoSorb | IL-6 | 48 hours after CPB | 89.0 pg/ml |
| CytoSorb | IL-6 | 120 hours after CPB | 0.4 pg/ml |
| CytoSorb | IL-6 | Preoperative | 0 pg/ml |
| CytoSorb | IL-6 | Before CPB | 0 pg/ml |
| CytoSorb | IL-6 | After CPB | 62.9 pg/ml |
| Control | IL-6 | 120 hours after CPB | 8.2 pg/ml |
| Control | IL-6 | 2 hours after CPB | 118.7 pg/ml |
| Control | IL-6 | Preoperative | 0 pg/ml |
| Control | IL-6 | 24 hours after CPB | 120.9 pg/ml |
| Control | IL-6 | After CPB | 63.6 pg/ml |
| Control | IL-6 | 48 hours after CPB | 67.7 pg/ml |
| Control | IL-6 | Before CPB | 0 pg/ml |