| CTRI Number |
CTRI/2025/04/085121 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of IgM-enriched immunoglobulin mixture in severe burn patients |
|
Scientific Title of Study
|
Use of IgM-enriched intravenous immunoglobulin mixture in patients with severe burn: a randomized placebo-controlled trial |
| 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 Premangshu Ghoshal |
| Designation |
Senior Resident (Academic) |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Room 5011, 5th Floor, Academic Building, Department office, Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
7003664307 |
| Fax |
|
| Email |
premangshu.ghoshal400@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailendra Kumar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Room Number 4, Porta Cabin, 5th Floor, Academic Building, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
7003664307 |
| Fax |
|
| Email |
drshail.kumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailendra Kumar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Room Number 4, Porta Cabin, 5th Floor, Academic Building, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
7003664307 |
| Fax |
|
| Email |
drshail.kumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, New Delhi
Address: Ansari Nagar, New Delhi - 110029, Country - India |
|
|
Primary Sponsor
|
| Name |
Dr Premangshu Ghoshal |
| Address |
Room Number 5011, 5th Floor, Academic Building, Department Office, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi, Ansari Nagar, New Delhi 110029, Country - India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shailendra Kumar |
Porta Cabin, 5th Floor, Academic Building, AIIMS New Delhi 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Premangshu Ghoshal |
All India Institute Of Medical Sciences, New Delhi |
BPS5 ICU, 5th Floor, Burn and Plastic Surgery Building, AIIMS New Delhi 110029
and
Room Number 5011, 5th Floor, Academic Building, Department office, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi 110029
New Delhi
DELHI |
7003664307
premangshu.ghoshal400@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee For Post Graduate Research, All India Institute Of Medical Sciences, Ansari Nagar, New Delhi 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T312||Burns involving 20-29% of body surface, (2) ICD-10 Condition: T313||Burns involving 30-39% of body surface, (3) ICD-10 Condition: T314||Burns involving 40-49% of body surface, (4) ICD-10 Condition: T315||Burns involving 50-59% of body surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IgM-enriched immunoglobulin infusion |
5 ml/kg ideal body weight of IgM-enriched intravenous immunoglobulin infusion daily on three consecutive days at a rate of 0.4 ml/Kg/hour starting after 48 hours of burn injury |
| Comparator Agent |
Normal Saline |
0.9% Normal Saline intravenous infusion of 5 ml/kg ideal body weight for 3 consecutive days at a rate of 0.4 ml/kg/hour starting after 48 hours of burn injury |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with 20% -60% TBSA (Total Body Surface Area) burn |
|
| ExclusionCriteria |
| Details |
1. Refusal to consent.
2. Patients with associated incurable metastatic malignant disease or unstable hematological malignancies, uncontrolled diabetics, cardiac diseases.
3. Patient is a known case of Hypersensitivity to human immunoglobulin, such as may occur in pathological immunoglobulin-G or immunoglobulin-A deficiencies.
4. Pregnant or Lactating females
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality |
at 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of stay in the ICU |
Till ICU discharge/death |
| Duration of stay in the hospital |
Till discharge from hospital/death |
| Change in SOFA Score |
over 30 days |
| Vasopressor requirement |
over 30 days |
| Duration of mechanical ventilation |
within 30 days |
| Requirement of Renal Replacement Therapy (RRT) |
in 30 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
29/04/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Burns, especially severe burns, can lead to extensive damage to the skin tissue, the body’s first defense barrier, resulting in serious damage to the body’s internal homeostasis, a decrease in immunity, and a large volume of necrotic wound tissue. These changes provide good conditions for the growth and reproduction of bacteria. In patients with severe burn injuries, both local and systemic immunoglobulin or antibody levels have been shown to be significantly decreased during the first 48 hours following burn injuries with serum levels remaining low for weeks in some patients predisposing them to multiple infections. Polyclonal Intravenous immunoglobulins, which have pleiotropic effects on inflammatory and immune mechanisms, represent a promising therapy to modulate both the pro- and anti-inflammatory processes as well as replenishing the humoral immunity and can contribute to the elimination of pathogens. It will be interesting to see whether administration of IgM-enriched Immunoglobulin mixture in severe burns can help in preventing development of sepsis by countering the immune response and reducing subsequent mortality which may have the potential in changing management protocol in burn patients in near future. |