Cytokine Filter Usage During Open Thoracoabdominal Aortic Aneurysm Repair- a Single-center Randomized Prospective Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cytokine Filter Usage During Open Thoracoabdominal Aortic Aneurysm Repair- a Single-center Randomized Prospective Trial- Cytosorb and Its Imapct on Open TAAA Repair Outcome

Conditions
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Postoperative Complications, Inflammatory Response

Intervention / Treatment
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* Device: Cytosorb


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suffering from a TAAA larger than 55mm Exclusion Criteria: immunosupprive therapy pregnancy -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAAA patients with Cytosorb<br>Patients suffering from a TAAA larger than 55mm | Device: Cytosorb<br>* Cytokine filter, which can be used intraoperatively while using a heart lung machine<br>|
| TAAA patients without Cytosorb<br>Patients suffering from a TAAA larger than 55mm | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of perioperative catecholamine usage in mg/dl for the first seven days after surgery | amount measured in mg/dl | 7 days perioperatively -10 day postoperatively | 
| Amount of transfusion required during and after the surgery, assessed in transfusion more or less than 5 blood bags | packed cells, erythrocyte concentrate | 7 days perioperatively 5-10 day postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury, measured using serum creatinine in mg/dl | AKI assessed according to the KDIGO classification perioperatively for the first 7 days after surgery | 7 days perioperatively, -10 day postoperatively | 
| Patients survival for the first 12 months after surgery | Survival yes/no within the first 12 months after surgery | 12 months 10-14 months postopertaibely |