Cytokine Filter Usage During Open Thoracoabdominal Aortic Aneurysm Repair- a Single-center Randomized Prospective Trial
- Conditions
- Postoperative ComplicationsInflammatory Response
- Interventions
- Device: Cytosorb
- Registration Number
- NCT04765748
- Lead Sponsor
- RWTH Aachen University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Suffering from a TAAA larger than 55mm
immunosupprive therapy pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TAAA patients with Cytosorb Cytosorb Patients suffering from a TAAA larger than 55mm
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
Trial Locations
- Locations (1)
Alexander Gombert
🇩🇪Aachen, NRW, Germany
Alexander Gombert🇩🇪Aachen, NRW, Germany