Observational study to assess the outcome of purification system that aims to decrease the immunity in patients undergoing aortic surgery.
Not Applicable
- Conditions
- Health Condition 1: I712- Thoracic aortic aneurysm, withoutrupture
- Registration Number
- CTRI/2022/11/047314
- Lead Sponsor
- Medanta The Medicity
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Intra and post operative hemodynamic stability as evidenced by relative difference of the vasopressor requirement. <br/ ><br>2.Assessment of device related adverse events during study period.Timepoint: T1(Baseline) <br/ ><br>T2(2hours after Discontinuation of CPB) <br/ ><br>T3(24 hours after Discontinuation of CPB) <br/ ><br>T4(48 hours after Discontinuation of CPB) <br/ ><br>T5(15 days after Surgery)
- Secondary Outcome Measures
Name Time Method Evaluation of IL-6,CRP,Procalcitonin,lactate levels. <br/ ><br>2. Need and duration of renal replacement therapy. <br/ ><br>3.Stroke/cerebrovascular accidents <br/ ><br>4.low cardiac output: cardiac index2.0L/min/m2. <br/ ><br>5.Duration of Mechanical Ventilation <br/ ><br>6.30 day Mortality <br/ ><br>7.Need for mechanical circulatory support (IABP/ECMO) <br/ ><br>8.Multi organ dysfunction syndrome <br/ ><br>Timepoint: T1(Baseline) <br/ ><br>T2(2hours after Discontinuation of CPB) <br/ ><br>T3(24 hours after Discontinuation of CPB) <br/ ><br>T4(48 hours after Discontinuation of CPB) <br/ ><br>T5(15 days after Surgery)