Removal of Cytokines in Patients Undergoing Cardiac Surgery With CPB (The REMOTE Study)
| Registry | NCT03104179, acronym REMOTE |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 80 (Estimated) |
| Sponsor | Klinikum Nürnberg (Other); collaborators: CytoSorbents, Inc |
| Conditions | Extracorporeal Circulation, Hemofiltration |
| Interventions | Cytosorb Adsorber (Device) |
| Dates | start 2017-05-01 (estimated), primary completion 2019-05-01 (estimated), completion 2019-05-01 (estimated), first posted 2017-04-07, last updated 2017-04-07 |
| Locations | 1 site in Germany |
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In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release of cytokines during immunological response.
They are induced by different types of inductors ( intrinsic and extrinsic). High levels of inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours of surgery.
Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These changes lead to rheology impairments.
These strong reactions lead to dysfunction of different organs possibly culminating in a multi organ failure.
There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB with a rate of about 30%. Dysfunctions of organ function are often connected with increased mortality, prolonged mechanical ventilation , septic complications, increased catecholamine dosages and prolonged length of ICU stay.
Use of cytokine adsorption within the extracorporeal circuit during CBP can affect the circulating cytokine levels during and after CPB and lead to a diminished inflammatory response, acute phase reaction as well as reduction of organ failure.
In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release of cytokines during immunological response.
They are induced by different types of inductors ( intrinsic and extrinsic). High levels of inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours of surgery.
Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These changes lead to rheology impairments.
These strong reactions lead to dysfunction of different organs possibly culminating in a multi organ failure.
There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB with a rate of about 30%. Dysfunctions of organ function are often connected with increased mortality, prolonged mechanical ventilation , septic complications, increased catecholamine dosages and prolonged length of ICU stay.
Use of cytokine adsorption within the extracorporeal circuit during CBP can affect the circulating cytokine levels during and after CPB and lead to a diminished inflammatory response, acute phase reaction as well as reduction of organ failure.
Official Title: Removal of Cytokines in patients undergoing cardiac surgery with CPB ( The REMOTE Study)
Study type: Interventional Study design: randomized, controlled Endpoint Classification: Efficacy study Interventional Model: Parallel assignment Masking: Single blinding ( Subject) Primary purpose: Treatment
Patients who have an elective cardiac surgery with an expected CPB duration > 75 min ( e.g. valve surgery, CABG, combined procedures, redo) will be enrolled into the study after a giving informed consent.
Selection of patients are directed by randomization. Patient which drop out will be replaced.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Treatment | Experimental | Device: Cytosorb Adsorber | CPB with Cytosorb |
| Control | No intervention | CPB without Cytosorb (Control) |
Sex: All, ages: 65 Years to 85 Years
Inclusion Criteria: * Elective cardiac surgery with CPB * Signed informed consent * CPB time > 75 min. * Comorbidities: * diabetes mellitus * CHF, NYHA class 1 and 2 * liver dysfunction (1, 2) * kidney dysfunction (1, 2) * hypertension * arteriosclerosis Exclusion Criteria: * Age < 65 years * Declined informed consent * Planed temperature < 32 C * Emergency surgery * Preexisting renal replacement therapy * Preexisting kidney transplantation * Administration of immunosuppressants like steroids * AIDS with CD 4 < 200/ * Participation in other trials
| Facility | City | Country | Status |
|---|---|---|---|
| Klinikum Nürnberg - Nuremberg Hospital | Nuremberg, Bavaria | Germany |