| CTRI Number |
CTRI/2025/12/099968 [Registered on: 31/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A hospital study comparing the standard treatment of burns alone with treatment involving infusion of N Acetyl Cysteine on inflammatory markers and clinical outcomes in patients involving 20 to 60 percentage body surface area |
|
Scientific Title of Study
|
An Open Label Randomized controlled trial comparing the effect of intravenous N Acetyl Cysteine infusion with standard care vs standard care alone on inflammatory markers and clinical outcomes in patients with burns involving 20 to 60 percentage BSA |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sai Pavan Ganji |
| Designation |
MD Anaesthesiology |
| Affiliation |
AIIMS Delhi |
| Address |
Department of Anaesthesiology, Pain medicine and critical care, Academic block, 5th floor, AIIMS Delhi, Ansari nagar east, New Delhi, Delhi 110049
All India Institute Of Medical Sciences,Ansari nagar east, New Delhi, Delhi 110049
New Delhi
DELHI
110049
India |
| Phone |
9676916702 |
| Fax |
|
| Email |
spvn123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Vanlal Darlong |
| Designation |
Professor |
| Affiliation |
AIIMS Delhi |
| Address |
Department of Anaesthesiology, 5th floor, Academic block, AIIMS Delhi, Ansari nagar east, New Delhi, Delhi
All India Institute Of Medical Sciences,Ansari nagar east, New Delhi, Delhi 110049
New Delhi
DELHI
110049
India |
| Phone |
9676916702 |
| Fax |
|
| Email |
darlongv@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sai Pavan Ganji |
| Designation |
MD Anaesthesiology |
| Affiliation |
AIIMS Delhi |
| Address |
Department of Anaesthesiology, 5th floor,Academic block,All India Institute Of Medical Sciences,Ansari nagar east, New Delhi, Delhi 110049
All India Institute Of Medical Sciences,Ansari nagar east, New Delhi, Delhi 110049
DELHI
110049
India |
| Phone |
9676916702 |
| Fax |
|
| Email |
spvn123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sai Pavan Ganji |
| Address |
House number 183A1, Gautham nagar, New Delhi 110049 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vanlal Darlong |
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 Sai Pavan Ganji |
AIIMS NEW DELHI |
BPSS ICU, 5th Floor, Burn and Plastic Surgery Building, Aiims New Delhi, Delhi,110029
New Delhi
DELHI |
9676916702
spvn123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR POST GRADUATE RESEARCH |
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 |
| Comparator Agent |
CONTROL GROUP |
Patients in the control group would receive usual care of burns management as per AIIMS protocol |
| Intervention |
NAC Group (Interventional arm) |
Eligible patients after randomization will be receiving IV N-Acetyl cysteine infusion (150mg/kg bolus dose followed by 12mg/kg/hr) from day 1 to day 5 (Total duration:5 days) of admission in to burn icu. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Sustained thermal burns involving more than20% TBSA
Admitted within 24 hours of injury
Provided informed consent (or consent from legal surrogate if incapacitated)
|
|
| ExclusionCriteria |
| Details |
Known or suspected inhalation injury requiring mechanical ventilation at presentation
Pre-existing chronic liver or kidney disease
Known allergy or contraindication to N-acetylcysteine
Patients receiving chronic immunosuppressive therapy or corticosteroids
Pregnancy or lactation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum IL-6 levels on day 5 of hospital admission |
Serum IL-6 levels on day of admission and on day 5 of admission in burn icu |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum CRP levels |
Day of admission and day 5 of admission in burn icu |
| Serum creatine kinase levels |
On day of admission and on day 5 of admission in burn icu |
| Lung Injury Score (LIS) |
on day of admission and on day 5 of admission in burn icu |
| Requirement of vasopressors (presence and dose by day 5) |
Daily from the day of admission in ICU up to 5 days |
| Length of ICU stay |
Till the time patient either expires or gets shifted out of ICU |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/01/2026 |
| 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) |
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
|
Burns
involving more than 20% BSA mount a significant inflammatory response leading
to endothelial dysfunction, capillary leak and multi-organ complications
NAC,
which is a potent anti-oxidant has been shown to reduce this inflammatory surge
in various critical illnesses
However,
its role in major burn patients remains inadequately studied with limited
evidence on its effect on inflammatory markers
This
study aims to evaluate whether intravenous NAC can attenuate systemic
inflammation in patients with burns more than 20% BSA |