Albumin and Prognosis of Severely Burned Patients Retrospective, Prospective, Observational Study for the BurnICU Group of ESICM
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The primary endpoint will be a combined endpoint of mortality, stage 3 acute renal failure and severe acute respiratory distress syndrome within 28 days of burn injury.
研究概览
简要总结
Hemodynamic management has long been identified as a key factor affecting burn prognosis. However, large amounts of crystalloid infusion have been associated with the development or aggravation of organ failure (acute respiratory distress syndrome, vascular injury, acute renal failure, and intra-abdominal hypertension) which worsens the final prognosis.
The use of albumin during the first 24 hours of burn resuscitation is controversial since capillary leakage may cause transcapillary passage of large molecules into the interstitial space. In fact, human albumin has multiple physiological effects, including regulation of colloidal osmotic pressure, antioxidant properties, nitric oxide modulation and buffering capacities, plasma binding and transport of various substances, which may be particularly important in severe burns.
Currently available data suggest that administration of exogenous albumin during the first 24 hours of resuscitation of severe burn patients may be associated with improved outcomes. Multi-centre randomized controlled trials with adequate power should be undertaken in burned patients.
详细描述
In the participating centers: severe burn adult patients with a TBSA burn >30% will be included and followed for 90 days after admission. This observational study will allow us to collect and analyze data in order to design a quality interventional trial evaluating the value of albumin in the initial management of the severely burned patient.
The primary objective of the study is to describe the incidence of a combined endpoint of mortality, severe acute renal failure (stage 3) and severe acute respiratory distress syndrome in severely burned patients.
Secondary Objectives
- Describe the prognosis of patients with severe burns, with particular emphasis on the impact of albumin on the prognosis of patients with severe burns.
- Describe how albumin is administered (i.e. doses, duration of treatment, continuous vs. bolus administration, hyperoncotic vs. hypooncotic solutions, etc.).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Burns > 30% SCT
- •Patients admitted to the ICU within 12 hours of a burn.
排除标准
- •Pregnancy
- •Patients with a limitation of active therapeutics on admission to BICU
- •Pre-hospital cardiac arrest
- •Moribund patients: pre-hospital cardiac arrest, CBS burn >95%.
- •Age >80 years
结局指标
主要结局
The primary endpoint will be a combined endpoint of mortality, stage 3 acute renal failure and severe acute respiratory distress syndrome within 28 days of burn injury.
时间窗: 28 days of burn injury
次要结局
- Rate of patients with Sepsis and septic shock(Days 28 and 90)
- Rate of patients with Acute respiratory distress syndrome (ARDS) on days 28 and 90(days 28 and 90 of burn injury)
- SOFA Score(between Day 1 and Day 7)
- Rate of patients with acute renal failure on days 28 and 90(days 28 and 90 of burn injury)
- Rate of patients with Acute Abdominal Compartment Syndrome(days 28 and 90 of burn injury)