A Prospective observational study to evaluate the outcome of cytokine hemadsorption during aortic surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medanta The Medicity
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- 1. Intra and post operative hemodynamic stability as evidenced by relative difference of the vasopressor requirement.
Study Overview
Brief Summary
The Hypothesis of this study is that Cytokine removal using Cytosorb therapy during cardiopulmonary bypass (CPB) significantly reduces Hyperinflammation and improves Hemodynamic stability in patients undergoing Aortic Surgery.
This study will enable to assess the impact of the treatment with Cytosorb 300 ml device on the course of hyperinflammation, hemodynamic stability and multi-organ failure in patients undergoing CPB assisted surgery for aortic diseases.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All patients above 18 years of age giving consent eligible for Elective aortic surgery under Cardiopulmonary Bypass.
Exclusion Criteria
- •Patients below 18 years of age Patient did not provide consent Emergency surgery patients Patients undergoing aortic dissection Infective Endocarditis Moribund patients expected to die <24 hours Patients receiving chemotherapy, immunosuppressants and steroids.
Outcomes
Primary Outcomes
1. Intra and post operative hemodynamic stability as evidenced by relative difference of the vasopressor requirement.
Time Frame: T1(Baseline) | T2(2hours after Discontinuation of CPB) | T3(24 hours after Discontinuation of CPB) | T4(48 hours after Discontinuation of CPB) | T5(15 days after Surgery)
2.Assessment of device related adverse events during study period.
Time Frame: T1(Baseline) | T2(2hours after Discontinuation of CPB) | T3(24 hours after Discontinuation of CPB) | T4(48 hours after Discontinuation of CPB) | T5(15 days after Surgery)
Secondary Outcomes
- Evaluation of IL-6,CRP,Procalcitonin,lactate levels.(2. Need and duration of renal replacement therapy.)