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CTRI Number  CTRI/2024/01/061901 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   An observational study was conducted in many countries to collect data regarding the current treatment practices and their outcomes in a patient with weak immunity who was admitted to the intensive care unit with severe difficulty in breathing for improvement in future treatment practices. 
Scientific Title of Study   A Multicenter Study to Improve Management and Outcomes In Immunocompromised Patients with Acute Respiratory Failure 
Trial Acronym  EFRAIM 3 
Secondary IDs if Any  
Secondary ID  Identifier 
Project no 4164 Version 1.0 dated 15.03.2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesia, Critical Care and Pain, Second Floor Main Buidling TMH, Dr E Borges Road, Parel, Mumbbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesia, Critical Care and Pain, Second Floor Main Buidling TMH, Dr E Borges Road, Parel, Mumbbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesia, Critical Care and Pain, Second Floor Main Buidling TMH, Dr E Borges Road, Parel, Mumbbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai-12 
 
Primary Sponsor  
Name  Groupe de Recherche respiratoire en Réanimation Onco Hématologique 
Address  Intensive Care Department, Saint-Louis Hospital and Paris Cité University, 1 avenue Claude Vellefaux, 75010 Paris, FRANCE 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Not Any  Not Any 
 
Countries of Recruitment     Egypt
France
Germany
Iceland
India
Italy
Mexico
Myanmar
Netherlands
New Zealand
United States of America
Australia
Bangladesh
Belgium
Bhutan
Brazil
Greece
Hong Kong
Japan
Norway
Pakistan  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sheila N Myatra  Tata Memorial Hospital  MB117 and MB 214, Intensive Care Unit, Main Building First and second floors, Tata Memorial Hospital, Dr E Borges road, Parel,
Mumbai
MAHARASHTRA 
9820156070

sheila150@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee-I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J960||Acute respiratory failure, (2) ICD-10 Condition: D849||Immunodeficiency, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 adult patients
2 admitted to the ICU between 1 Jan 2017 to 31 Dec 2022
3. with acute respiratory failure oxygen dependance more than 6 liter per min to achieve SPO2 more than 92 percentage and or respiratory rate more than 30 per minute and or labored breathing and or the need for non invasive or invasive mechanical ventilation or high flow nasal cannula
4 with a known immunodepression hematological malignancy including autologous and allogeneic stem cell transplant, solid tumor requiring treatments over the last five years, solid organ transplant, immunosuppressive drugs for auto-immune or auto inflammatory disease and primary immunodeficeincy  
 
ExclusionCriteria 
Details 
1. Patients with isolated HIV infection are not eligible for this study
2. Patients already included in the cohort
3. Patient refuse for consent and data collection
4. Patients deprived of liberty under guardianship or curatorship
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mortality risk factors in the short and medium term  survival at 3 months of immunocompromised patients after ICU admission 
 
Secondary Outcome  
Outcome  TimePoints 
to identify the prognostic factors for day-90 mortality.  90 days from the date of ICU admission 
A comparison between different intensive care units in terms of mortality and management strategies.  comparison of factor affecting the 90 days mortality  
 
Target Sample Size   Total Sample Size="10000"
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)   31/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/11/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

We designed this multicenter retrospective study to appraise outcomes in immunocompromised patients with ARF. Our research group includes about seventy intensive care units in sixteen countries. Five more countries have decided to join our group starting with this study (see appendix 1). Participating centers are clinical experts in the field of critical care and are dedicated to the care of critically ill immunocompromised patients.

Inclusion criteria are:

a) adult patients

b) admitted to the ICU between January 1, 2017 and December 31, 2022

c) with acute respiratory failure (oxygen dependence >6l/min to achieve a SpO2>92 and/or respiratory rate >30/min and/or laboured breathing and/or the need for non-invasive or invasive mechanical ventilation or high-flow nasal canula;

d) with a known immunodepression (hematological malignancy (including autologous and allogeneic stem cell transplant), solid tumor requiring treatements over the last five years, solid organ transplant, immunosuppressive drugs for auto-immune or auto-inflammatory diseases, and primary immunodeficiency). Patients with isolated HIV infection are not eligible for this study.

The primary objective is mortality 90 days after ICU admission, with a specific attention to outcomes in patients with undetermined ARF etiology. Secondary objectives are the determinants of escalation from standard oxygen therapy to the ceiling of therapy, including intubation, rescue strategies to optimize oxygenation in ARDS, and ECMO. Variables will also be collected to better assess the center effect. This will be the largest cohort of immunocompromised patients with ARF. We ambition to provide updated benchmarks on the management and outcomes of these patients and identify areas for improvement in care and generate hypotheses to improve practices.

 
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