Anti-inflammatory effects of Metformin in adults with moderate to major burns (20-60 percentage TBSA): A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the effects of Metformin on Serum levels of CRP, IL-6, Serum Ferritin, and PCT in adult burn patients with. 20-60 percentage of TBSA injuries.
研究概览
简要总结
| This study explores a novel use of a well-known drug to address a serious unmet need in burn care, with the potential to transform treatment protocols and improve survival. |
1. High Burden of Burn-Related Inflammation
Burn injuries involving 20–60 percent of the TBSA induce a strong systemic inflammatory response. This excessive inflammation often leads to life-threatening complications such as sepsis, acute organ failure, and death. Current treatments primarily focus on supportive care, with limited options to directly modulate the inflammatory response.
2. Need for Adjunctive Therapies
Despite advances in critical care, mortality and morbidity rates in moderate to severe burn patients remain high. Introducing safe, accessible, and cost-effective therapies that can reduce inflammation could significantly improve patient outcomes.
3. Metformin’s Unique Therapeutic Potential
Metformin is widely used, well-tolerated, and inexpensive. Its anti-inflammatory properties, mediated via AMPK activation and NF-kappa B inhibition, provide a strong biological rationale for investigating its use beyond diabetes—especially in conditions characterized by excessive cytokine release, such as burns.
4. Lack of Prior Research in Burn Populations
While metformin’s anti-inflammatory effects have been studied in other diseases (e.g., cardiovascular disease, diabetes, cancer), there is limited research specifically evaluating its role in burn-induced inflammation. This study would help fill that critical knowledge gap.
5. Potential to Improve Clinical Outcomes
If metformin is shown to effectively reduce biomarkers like CRP, IL-6, Serum Ferritin and PCT in burn patients, it may lead to reduced sepsis rates, faster recovery, shorter ICU stays and lower healthcare costs, ultimately enhancing quality of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults aged 18–60 years.
- •Burns covering 20–60 percentage of TBSA.
- •3.Provision of informed consent by the patient or legal representative.
- •Hemodynamically stable.
排除标准
- •Known history of diabetes mellitus.
- •Serum creatinine greater than 1.5 mg/dL
- •Hepatic dysfunction (AST or ALT greater than 3 times the upper limit of normal).
- •Presence of lactic acidosis or metabolic acidosis.
- •Pregnancy or lactation.
- •Participation in another interventional clinical trial.
结局指标
主要结局
To evaluate the effects of Metformin on Serum levels of CRP, IL-6, Serum Ferritin, and PCT in adult burn patients with. 20-60 percentage of TBSA injuries.
时间窗: Till 7 days of ICU admission or till discharge whichever is earlier
次要结局
- To assess the impact of metformin on clinical outcomes, including:(a. Sequential Organ Failure Assessment (SOFA) score)
研究者
Satish Harkal
All India Institute of Medical Sciences (AIIMS), New Delhi.
