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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

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 - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099968
Enrollment
60
Registered
2025-12-31
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: T312- Burns involving 20-29% of body surface Health Condition 2: T313- Burns involving 30-39% of body surface Health Condition 3: T314- Burns involving 40-49% of body surface Health Condition 4: T315- Burns involving 50-59% of body surface

Interventions

Intervention1: 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 (T

Sponsors

Dr Sai Pavan Ganji
Lead Sponsor
Dr Vanlal Darlong
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Sustained thermal burns involving more than20% TBSA Admitted within 24 hours of injury Provided informed consent (or consent from legal surrogate if incapacitated)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Serum IL-6 levels on day 5 of hospital admissionTimepoint: Serum IL-6 levels on day of admission and on day 5 of admission in burn icu—

Secondary

MeasureTime frame
Serum CRP levelsTimepoint: Day of admission and day 5 of admission in burn icu;Serum creatine kinase levelsTimepoint: On day of admission and on day 5 of admission in burn icu;Lung Injury Score (LIS)Timepoint: on day of admission and on day 5 of admission in burn icu;Requirement of vasopressors (presence and dose by day 5)Timepoint: Daily from the day of admission in ICU up to 5 days;Length of ICU stayTimepoint: Till the time patient either expires or gets shifted out of ICU—

Countries

India

Contacts

Public ContactSai Pavan Ganji

AIIMS Delhi

darlongv@yahoo.com9676916702

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026