| 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
|
|
|
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. |