Observational study to assess the outcome of purification system that aims to decrease the immunity in patients undergoing aortic surgery.

Completed

• Conditions: Thoracic aortic aneurysm, withoutrupture,

• Registration Number: CTRI/2022/11/047314
• Lead Sponsor: Medanta The Medicity

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-18
• Study Completion: 2023-06-25
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

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.	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.	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 Outcome Measures

Name	Time	Method
Evaluation of IL-6,CRP,Procalcitonin,lactate levels.	2. Need and duration of renal replacement therapy.

Trial Locations

Locations (1)

Medanta The Medicity; 🇮🇳 Gurgaon, HARYANA, India

Medanta The Medicity

🇮🇳Gurgaon, HARYANA, India

DrMandeep Singh

Principal investigator

8360477299

mandeep.singh1@medanta.org