Removal of Cytokines in Patients Undergoing Cardiac Surgery With CPB (The REMOTE Study)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Klinikum Nürnberg
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Cytokine levels following CPB
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 65 Years to 85 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment
CPB with Cytosorb
Intervention: Cytosorb Adsorber (Device)
Control
CPB without Cytosorb (Control)
Outcomes
Primary Outcomes
Cytokine levels following CPB
Time Frame: 72 hours
Evaluation of cytokine adsorber effect on cytokine levels intra- and post
Secondary Outcomes
- Level of haptoglobin(72 hours)
- Intra- and postoperative catecholamine dosages(until ICU discharge, expected average 4 days)
- Level of transferrin(72 hours)
- postoperative renal failure necessitating RRT(until ICU discharge, expected average 4 days)
- Level of ferritin(72 hours)
- Length of ICU stay(until discharge from ICU, expected average 4 days)
- Length of hospital stay(up to hospital discharge, expected average 14 days)
Investigators
PD Dr. med. Giuseppe Santarpino
PD, Dr. med
Klinikum Nürnberg