| 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
|
|
|
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
|
|
|
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. |