TAAA-Cytosorb: Cytokine Filter Usage During Open Thoracoabdominal Aortic Aneurysm Repair- a Single-center Randomized Prospective Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| TAAA patients with Cytosorb Patients suffering from a TAAA larger than 55mm |
Device: Cytosorb
Cytokine filter, which can be used intraoperatively while using a heart lung machine
|
| TAAA patients without Cytosorb Patients suffering from a TAAA larger than 55mm |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
Suffering from a TAAA larger than 55mm
Exclusion Criteria:
immunosupprive therapy pregnancy
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Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alexander Gombert | Aachen | NRW | Germany | 52074 |
Sponsors and Collaborators
- RWTH Aachen University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-031