Inflammatory Response, Postoperative Complications
Conditions
Brief summary
Prospecrtive study including 20-30 randomized patients treated by open repair because of an TAAA larger than 55 mm During the surgery, a heart lung machine is applied for distal perfusion during aortic cross clamping to enable distal organ perfusion. Regardless an intensive inflammatory reaction is a well known effect after reperfusion, leading to a uncontrolled inflammation during th first days after surgery. This may be associated to bad outcome and decreased survival rates. By the application of a intraoperative cytokine and DAMP filter this negative ffect could be reduced, resulting in a better outcome after surgery.
Detailed description
Prospecrtive study including 20-30 randomized patients treated by open repair because of an TAAA larger than 55 mm During the surgery, a heart lung machine is applied for distal perfusion during aortic cross clamping to enable distal organ perfusion. Regardless an intensive inflammatory reaction is a well known effect after reperfusion, leading to a uncontrolled inflammation during th first days after surgery. This may be associated to bad outcome and decreased survival rates. By the application of a intraoperative cytokine and DAMP filter this negative ffect could be reduced, resulting in a better outcome after surgery.
Interventions
DEVICECytosorb
Cytokine filter, which can be used intraoperatively while using a heart lung machine
Sponsors
RWTH Aachen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Inclusion criteria
Suffering from a TAAA larger than 55mm
Exclusion criteria
immunosupprive therapy pregnancy \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of perioperative catecholamine usage in mg/dl for the first seven days after surgery | 7 days perioperatively -10 day postoperatively | amount measured in mg/dl |
| Amount of transfusion required during and after the surgery, assessed in transfusion more or less than 5 blood bags | 7 days perioperatively 5-10 day postoperatively | packed cells, erythrocyte concentrate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury, measured using serum creatinine in mg/dl | 7 days perioperatively, -10 day postoperatively | AKI assessed according to the KDIGO classification perioperatively for the first 7 days after surgery |
| Patients survival for the first 12 months after surgery | 12 months 10-14 months postopertaibely | Survival yes/no within the first 12 months after surgery |
Countries
Germany
Outcome results
None listed