FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076281 [Registered on: 05/11/2024] Trial Registered Prospectively
Last Modified On: 04/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATIONAL 
Study Design  Other 
Public Title of Study   Role of Dialysis therapy in improving clinical outcomes and reduction in mortality of septic shock patients in icu. 
Scientific Title of Study   Efficacy of Haemoadsorption therapy in reducing Inflammatory markers in septic shock patients A Prospective observational study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pravin Kumar Das 
Designation  Professor Department of Anesthesiology and Critical Care  
Affiliation  Dr.Ram Manohar Lohia Institute Of Medical Sciences, Gomti Nagar, Lucknow-226010 
Address  Dr.Ram Manohar Lohia Institute Of Medical Sciences,Gomti Nagar,Lucknow-226010.

Lucknow
UTTAR PRADESH
226010
India 
Phone  9936565574  
Fax    
Email  drpkdasmadhubani@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Chakradhar.B.N 
Designation  Postgraduate Resident 
Affiliation  Dr.Ram Manohar Lohia Institute of Medical Sciences,Gomti Nagar, Lucknow-226010 
Address  Dr.Ram Manohar Lohia Institute of Medical Sciences,Gomti Nagar,Lucknow-226010.

Lucknow
UTTAR PRADESH
226010
India 
Phone  7904752436  
Fax    
Email  vnachegowda1997@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR CHAKRADHAR B N 
Designation  Postgraduate Resident 
Affiliation  Dr.Ram Manohar Lohia Institute Of Medical Sciences, Gomti Nagar, Lucknow-226010 
Address  DR.RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, GOMTI NAGAR, LUCKNOW-226010

Lucknow
UTTAR PRADESH
226010
India 
Phone  7904752436  
Fax    
Email  vnachegowda1997@gmail.com  
 
Source of Monetary or Material Support  
Dr.Ram Manohar Lohia Institute Of Medical Sciences,Gomti Nagar,Lucknow-226010 
 
Primary Sponsor  
Name  DrChakradharBN 
Address  Dr.RamManohar Lohia Institute Of Medical Sciences,Gomti Nagar, Lucknow-226010 
Type of Sponsor  Other [Self] 
 
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 
Dr Chakradhar BN  Dr.Ram Manohar Lohia Institute Of Medical sciences  Ims Building 1st Floor,Anaesthesia and CCM ICU,Combined Hospital Building EMERGENCY ICU,Gomti Nagar,Lucknow-226010
Lucknow
UTTAR PRADESH 
7904752436

vnachegowda1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr.Ritu Karoli, Co Member Secretary ,Institutional Ethics committee , Dr RMLIMS, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R652||Severe sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Patient in the age group of 18-70 years(Male and Female)
2) Written and informed consent from patient/family members
3)Patients with clinical diagnosis of Septic shock with adequate fluid resuscitation on ionotropes with ionotropic score more than 40 for atleast 2 hours, SOFA Score more than 8, Lactate level,more than 2.
 
 
ExclusionCriteria 
Details  Exclusion criteria:
1. Pre-existing chronic liver disease, chronic renal failure (estimated Glomerular Filtration rate less than 30ml/min)
2. Previous history of RRT or CRRT
.3 Immunodeficiency diseases such as tumors, connective tissue disease
.4 Immunosuppressive treatment other than recommended dose of steroids in ICU. 5. Patients with Autoimmune disorders
6. Other modalities of blood purification techniques used
7. Pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome: Asesment ni level of inflammatory markers (IL 6, TNF alpha) post haemoadsorption therapy.  Pre Procedure and Post procedure After 6 hours, 12 hours, 24 hours,72 hours, 5th day,7th day 
 
Secondary Outcome  
Outcome  TimePoints 

1. Reduction in need of vasopressor requirements. .
2 .Change in SOFA score
3.Length of ICU stay
4.7 day mortality 

1. Reduction in need of vasopressor requirements ( Post procedure After 6 hours, 12 hours, 24 hours,72 hours, 5th day,7th day)
2 .Change in SOFA score(Pre Procedure and Post procedure After 6 hours, 12 hours, 24 hours,72 hours, 5th day,7th day)
3.Length of ICU stay
4.7 day mortality 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Haemoadsorption an extracorporeal blood purification (EBP) technique
to filter cytokines and endotoxins.. This technique is b has been used ased on mass separation by a solid agent (sorbent) contained ni a cartridge. It has shown potential role ni sepsis ni eliminating soluble inflammatory mediators produced during the immune response ot the pathogen,as well as endotoxin produced by pathogenic microorganism and lowering cytokine levels !!
• Sepsis is a life-threatening organ dysfunction syndrome because of
a disordered host response after a host infection caused by pathogenic microorganisms . In septic shock, the dysregulated host response ot infectious pathogens leads ot a cytokine storm—the uncontrolled production and release of humoral pro- and anti- inflammatory mediators causing cytotoxicity and promoting the development of organ dysfunction and increased mortality .Removing cytokines from the blood can help mitigate inflammatory damage and prevent sepsis-related mortality. Various extracorporeal blood purification therapies have been used to remove excess of inflammatory mediators or microbial toxins to improve health outcomes of patients with severe sepsis.
HA380 (Jafron Biomedical Co., Ltd., ) is a CE-labeled haemoadsorption cartridge developed to treat patients with septic shock. It contains hemocompatible, porous polymeric beads that adsorb cytokines and mid-molecular-weight toxins onto the surface of the beads. The range of molecule sizes adsorbed by the HA380 lies in a range between 10-60 kDa . It has been reported that HA380 can adsorb several cytokines including IL-1, IL-6, IL-8, IL-10, and TNF-a IS ni addition ot complements, fre hemoglobin, and other molecules over a wide range of molecular weight ally il septic This study aimed to evaluate the effectiveness of haemoadsorption in criti-c1,Interleukin- shock patient for adsorption of endotoxin and cytokine.i.c.., Interleukin 6,Interleukin-8,Interleukin-10, TNF-Alpha.
 
Close