The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 52
- 主要终点
- Volume of fluid received during resuscitation for burn injury
研究概览
简要总结
This is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR alone), in adults with an acute burn involving at least 25% of their total body surface area.
详细描述
Enrolled subjects will be randomly assigned to either the Colloid Group or the Crystalloid Group. Randomization will be based on an intent-to-treat basis. In order to ensure that the two groups have comparable injury severity at baseline, randomization will be block- stratified based on age (18-50 and > 50 years), burn size (25-50% and > 50% TBSA), and presence of inhalation injury confirmed by bronchoscopy (present or absent). In the Colloid Group resuscitation starts with LR and then 5% albumin will be introduced between 8 and 12 hours post burn in a ratio of 1/3 albumin to 2/3 LR. In the Crystalloid Group resuscitation is with LR only. Each group will have their study fluid maintained for the 1st 48 hours post burn and study fluids in each group will be identically titrated to the urinary output.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Total burn size (second and third degree) is ≥ 25% of the TBSA
- •Burn center admission within 12 hours of injury.
- •There is a plan for formal fluid resuscitation.
排除标准
- •Significant associated trauma
- •High voltage (≥ 1000 volts) electrical burns
- •Burn wound excision surgery within 48 hours from injury
- •Fresh frozen plasma (FFP) given at any time ≤ 48 hours from injury
- •Hypertonic saline (HTS) given at any time ≤ 48 hours from injury
- •Hydroxyethyl starch (HES) given at any time ≤ 48 hours from injury
- •High dose Vitamin C infusion given at any time ≤ 48 hours from injury
- •Administration of human albumin prior to randomization
- •Palliative comfort measures are instituted ≤ 48 hours from injury
- •Pregnancy
- •Pre-injury chronic renal insufficiency equal to or greater than stage 3
- •Pre-injury chronic hepatic disease (Child-Pugh B or C)
- •Pre-injury left ventricular (LV) dysfunction (echocardiography LV grade II-IV or ejection fraction ≤ 35%)
研究组 & 干预措施
Crystalloid
Subjects in the crystalloid group will receive fluid resuscitation with Lactated Ringer's titrated each hour to achieve a urine output of 0.5-1mL/kg predicted body weight.
Colloid
Subjects in the colloid group will receive fluid resuscitation with Lactated Ringer's and 5% human albumin solution introduced no earlier than 8 hours post burn and no later than 12 hours post burn in a ratio by volume of 1/3 albumin to 2/3 Lactated Ringer's, and titrated each hour to achieve a urine output of 0.5-1mL/kg (milliliter/kilogram) predicted body weight.
干预措施: Albumin Human (Drug)
结局指标
主要结局
Volume of fluid received during resuscitation for burn injury
时间窗: 24 hours post burn injury
Total fluid resuscitation volume at 24 hours post burn in mL/kg/% TBSA burn
次要结局
- Peak lactate and delta lactate(48 hours post burn injury)
- Urine output during resuscitation for burn injury(24 and 48 hours post burn injury)
- Occurrence of Abdominal compartment syndrome(48 hours post burn injury)
- Peak intra-abdominal pressure (IAP) and delta IAP(48 hours post burn injury)
- Occurrence of Limb or abdominal fasciotomy(48 hours post burn injury)
- Time to wound healing(7 days post last surgery for grafting of burn injury)
- Volume of fluid received during resuscitation for burn injury(48 hours post burn injury)
- Number of crossovers(48 hours post burn injury)
- Sequential Organ Failure Assessment (SOFA) score(48, 72, and 96 hours post burn injury)
- Acute kidney injury (AKI)(96 hours post burn injury)
- Duration of intubation/mechanical ventilation(96 hours post burn injury)
- PaO2/FiO2 ratios(24, 48, 72, and 96 hours post burn injury)
- Survival(28 days post injury and hospital discharge)