Use of IgM-enriched intravenous immunoglobulin mixture in patients with severe burn: a randomized placebo-controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with 20% -60% TBSA (Total Body Surface Area) burn.
排除标准
- •Refusal to consent.
- •Patients with associated incurable metastatic malignant disease or unstable hematological malignancies, uncontrolled diabetics, cardiac diseases.
- •Patient is a known case of Hypersensitivity to human immunoglobulin, such as may occur in pathological immunoglobulin-G or immunoglobulin-A deficiencies.
- •Pregnant or Lactating females.
结局指标
主要结局
Mortality
时间窗: at 30 days
次要结局
- 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)
研究者
Dr Premangshu Ghoshal
All India Institute Of Medical Sciences, New Delhi
