Plasma Resuscitation WithOut Lung Injury
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 6
- 主要终点
- The total volume of all resuscitation fluids delivered between hours 0-24 postern, in ml/kg.
研究概览
简要总结
The treatment of patients with major burns requires resuscitation with massive amounts of fluid, typically a type of salt water that is given by vein. This frequently results in injury to vital organs, especially the lungs and kidneys, and even in death. In this study, the investigators propose to use plasma, a specially prepared blood product made from the liquid part of blood, that has undergone special treatment to reduce the risk of disease transmission. The aims include 1) reduce the amount of fluid given during the first 24 hours after a burn 2) reduce the incidence of lung injury and other complications related to the administration of funds and 3) determine if the blood product has any effect on inflammation. An overall decrease the amount of fluids that burn patients receive should decrease the potential for lung injury, decrease days in the hospital, and improve survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Weight > 40 kg
- •Initial assessment of thermal injury size ≥ 20% TBSA
- •Admitted to the burn center and enroll able within 8 hours of injury
- •Expected to receive intravenous resuscitation fluids for at least 24 hours after injury
- •Expected to live > 24 hours after injury
排除标准
- •Chemical injury
- •Deep electric injury
- •Associated non-thermal injuries with estimated Injury Severity Score > 25
- •Inability to obtain informed consent
- •Decision not to treat due to injury severity or other factors
- •Patient age > 65 years or < 18 years
- •Presence of anoxic brain injury that is not expected to result in complete recover
- •Patent already receiving plasma infusion, or judged to be likely to require plasma infusion
- •Patent already receiving "rescue procedures" (albumin infusion, CRRT, TPE, or high-dose ascorbic acid)
- •Existence of pre-morbid conditions: Congestive heart failure (NYHA Class IV); End-stage kidney disease (dialysis patient); Cirrhosis of the liver; Oxygen-dependent chronic obstructive pulmonary disease; Malignancy currently under treatment; Previous bilateral lower extremity amputations
研究组 & 干预措施
Plasma
Pathogen-Reduced Plasma resuscitation
干预措施: Pathogen-Reduced Plasma (Drug)
Crystalloid
Standardized crystalloid resuscitation
干预措施: Crystalloid Solutions (Drug)
结局指标
主要结局
The total volume of all resuscitation fluids delivered between hours 0-24 postern, in ml/kg.
时间窗: 24 hours
The total volume of all resuscitation fluids delivered between hours 0-24 postburn, in ml/kg
次要结局
- Metabolic acidosis(48 hours)
- Total resuscitation volume in ml/kg(48 hours)
- Total 24 hour resuscitation volume in ml/kg/TBSA(24 hours)
- Total 48 hour resuscitation volume in ml/kg/TBSA(48 hours)
- Hemodynamic instability(48 hours)
- Incidence of "rescue" (b)(48 hours)
- Incidence of "rescue" (a)(48 hours)
- Acute Respiratory Distress Syndrome(7 days)
- Cytokines(48 hours)
- Mechanical ventilation(28 days)
- Incidence of "rescue" (c)(24 hours)
- Intensive Care Unit days(28 days)
- Multi-Organ Failure Assessment(7 days)
- Thromboembolic events(7 days)
- Patient reported outcomes(6 months)
- Syndecan-1 levels(48 hours)
- Transfusion-Related Acute Lung Injury(72 hours)
- Mortality(throughout study completion, an average of 1 year)