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CTRI Number  CTRI/2022/11/047314 [Registered on: 15/11/2022] Trial Registered Prospectively
Last Modified On: 25/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Observational study to assess the outcome of purification system that aims to decrease the immunity in patients undergoing aortic surgery. 
Scientific Title of Study   A Prospective observational study to evaluate the outcome of cytokine hemadsorption during aortic surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mandeep Singh 
Designation  DNB Secondary Resident 
Affiliation  Medanta The Medicity 
Address  1st Floor, Medanta Institute of Critical Care and Anesthesia

Gurgaon
HARYANA
122001
India 
Phone  08360477299  
Fax    
Email  mandeep.singh1@medanta.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Yatin Mehta 
Designation  Chairman, Institute of Critical Care and Anesthesia 
Affiliation  Medanta The Medicity 
Address  1st Floor, Medanta Institute of Critical Care and Anesthesia

Gurgaon
HARYANA
122001
India 
Phone  01244141414  
Fax    
Email  yatinmehta@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mandeep Singh 
Designation  DNB Secondary Resident 
Affiliation  Medanta The Medicity 
Address  1st Floor, Medanta Institute of Critical Care and Anesthesia

Gurgaon
HARYANA
122001
India 
Phone  08360477299  
Fax    
Email  mandeep.singh1@medanta.org  
 
Source of Monetary or Material Support  
Cytosorbents Europe GmbH 
 
Primary Sponsor  
Name  Medanta The Medicity 
Address  Sector 38 Gurgaon Haryana 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrMandeep Singh   Medanta The Medicity  1st floor, Medanta Institute of Critical care and Anesthesia
Gurgaon
HARYANA 		 8360477299

mandeep.singh1@medanta.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medanta Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I712||Thoracic aortic aneurysm, withoutrupture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients above 18 years of age giving consent eligible for Elective aortic surgery under Cardiopulmonary Bypass. 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Intra and post operative hemodynamic stability as evidenced by relative difference of the vasopressor requirement.
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  
Outcome  TimePoints 
Evaluation of IL-6,CRP,Procalcitonin,lactate levels.
2. Need and duration of renal replacement therapy.
3.Stroke/cerebrovascular accidents
4.low cardiac output: cardiac index2.0L/min/m2.
5.Duration of Mechanical Ventilation
6.30 day Mortality
7.Need for mechanical circulatory support (IABP/ECMO)
8.Multi organ dysfunction syndrome
 		 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) 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/11/2022 
Date of Study Completion (India) 25/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Mehta Y, Singh A, Singh M, Bhan A, Trehan N. Impact of intraoperative haemoadsorption on outcomes of patients undergoing aortic surgery: a single-centre, prospective, observational study. Interdiscip Cardiovasc Thorac Surg. 2024 Mar 29;38(4):ivae050. doi: 10.1093/icvts/ivae050. PMID: 38514401; PMCID: PMC10984732. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mandeep.singh1@medanta.org].

  6. For how long will this data be available start date provided 01-05-2023 and end date provided 01-05-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
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.
 
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