Removal of Cytokines in Patients Undergoing Cardiac Surgery With CPB
- Conditions
- HemofiltrationExtracorporeal Circulation
- Interventions
- Device: Cytosorb Adsorber
- Registration Number
- NCT03104179
- Lead Sponsor
- Klinikum Nürnberg
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Cytosorb Adsorber CPB with Cytosorb
- Primary Outcome Measures
Name Time Method Cytokine levels following CPB 72 hours Evaluation of cytokine adsorber effect on cytokine levels intra- and post
- Secondary Outcome Measures
Name Time Method Level of haptoglobin 72 hours Impact of intraoperative Cytokine adsorption on iron metabolism
Intra- and postoperative catecholamine dosages until ICU discharge, expected average 4 days Impact of intraoperative Cytokine adsorption on hemodynamic stability
Level of transferrin 72 hours Impact of intraoperative Cytokine adsorption on iron metabolism
postoperative renal failure necessitating RRT until ICU discharge, expected average 4 days Impact of intraoperative Cytokine adsorption on postoperative organ function
Level of ferritin 72 hours Impact of intraoperative Cytokine adsorption on iron metabolism
Length of ICU stay until discharge from ICU, expected average 4 days Impact of intraoperative Cytokine adsorption on postoperative patient course
Length of hospital stay up to hospital discharge, expected average 14 days Impact of intraoperative Cytokine adsorption on postoperative patient course
Trial Locations
- Locations (1)
Klinikum Nürnberg - Nuremberg Hospital
🇩🇪Nuremberg, Bavaria, Germany