Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Infectious endocarditis (IE) and other severe infections are well-known to induce significant changes in the immune response including immune functionality in a considerable number of affected patients. In fact, numerous patients with IE develop a persistent functional immunological phenotype that can best be characterized by a profound anti-inflammation and/or functional anergy. This was previously referred to as "injury-associated immunosuppression (IAI)" by Pfortmüller et al., published in Intensive Care Medicine Experimental 2017. IAI can be assessed by measurement of cellular (functional) markers. Persistence of IAI is associated with prolonged ICU length of stay, increased secondary infection rates, and death. Immunomodulation to reverse IAI was shown beneficial in immunostimulatory (randomized controlled) clinical trials. CytoSorb® treatment is currently used as standard of care in some institutions in surgically treated IE patients. The investigators aim to investigate two accepted treatment protocols and aim to explore whether adsorption with a cytokine adsorption filter can increase immune competence in treated individuals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment protocol without adsorption | No Intervention | ||
| Treatment protocol with adsorption | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment protocol with adsorption | Other | Adsorption while patients are in the OR on the extracorporeal circuit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in quantitative expression of monocytic Human Leukocyte Antigen (mHLA)-DR expression (Antibodies per cell on Cluster of Differentiation (CD)14+ monocytes/macrophages, assessed using a quantitative standardized assay) | From baseline (pre-OR, t1) to day 1 post-OR (t3) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mHLA-DR from baseline (pre-OR) to post-Or and 3 days post-Or. | Course of mHLA-DR | Baseline (pre-OP) to post-OR and 3 days post-Or |
| Area under the curve of quantitative mHLA-DR expression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joerg C Schefold, MD | Contact | 0041-31-632 | 5397 | joerg.schefold@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Lars Englberger, MD | Inselspital, Bern University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Intensive Care Medicine | Recruiting | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32282706 | Derived | Gisler F, Spinetti T, Erdoes G, Luedi MM, Pfortmueller CA, Messmer AS, Jenni H, Englberger L, Schefold JC. Cytokine Removal in Critically Ill Patients Requiring Surgical Therapy for Infective Endocarditis (RECReATE): An Investigator-initiated Prospective Randomized Controlled Clinical Trial Comparing Two Established Clinical Protocols. Medicine (Baltimore). 2020 Apr;99(15):e19580. doi: 10.1097/MD.0000000000019580. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004696 | Endocarditis |
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
Not provided
Not provided
| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| D000327 | Adsorption |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Area under the curves mHLA-DR
| Between baseline (pre-OR), post-OR, and day 1 and 3 post-OR (multiple assessments). |
| Change in inflammatory markers including cytokines (Interleukin (IL)-6, IL-10, C-reactive protein, White blood cell count, multiplex Enzyme linked immunosorbent assay, and inflammatory prohormones) | Change in inflammatory parameters | From baseline (pre-OR) to post-OR, and day 1 and 3 post-OR |
| Change in organ dysfunction (Sepsis-related organ failure (SOFA) scores incl. subscores and Simplified acute physiology score (SAPS II scores) daily | Course of organ dysfunction | 7-day timeframe (starting from ICu admission, assessed at day 90) |
| Length of ICU and hospital stay (days after surgical intervention). | Length of stay | Number of days on ICU and in hospital (assessed at day 90) |
| Cumulative Therapeutic Intervention Scoring System (TISS) points (resource need) until ICU-discharge | Resource use | Total number of TISS points on ICU (cumulative), assessed at day 90 |
| Total amount of infused volume/transfusions on ICU | Need for fluid therapy | 90 days |
| Duration of vasoactive drug therapy | Vasopressor use | 90 days |
| Duration of invasive mechanical ventilation | Use of organ support therapy (number of days on mechanical ventilation) | 90 days |
| ICU mortality rate | Number of non-surviving patients in both study groups | ICU stay (assessed at day 90) |
| Hospital mortality rate | Number of non-surviving patients in both study groups | hospital stay (assessed at day 90) |
| 28 day mortality rate | Number of non-surviving patients in both study groups | 28 days beginning from ICU admission (assessed at day 90) |
| 90 day mortality rate | Number of non-surviving patients in both study groups | 90 days beginning from ICU admission (assessed at day 90) |
| Duration of renal replacement therapy | Use of organ support therapy (number of days on renal replacement therapy) | 90 days |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D017530 | Health Care Quality, Access, and Evaluation |
| D055585 | Physical Phenomena |
| D055598 | Chemical Phenomena |