The Acute Burn Resuscitation Multicenter Prospective Observational Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Fluid resuscitation volume
研究概览
简要总结
This is a prospective, non-interventional, observational study of consecutive burn patients admitted to 20 selected burn centers in North America. Primarily, data collection will be continuous "real-time" documentation of fluid infusion rates, vital signs and laboratory values of patients receiving fluid resuscitation during the first 48 hours following burn injury. All aspects of the resuscitation and all investigations performed will be according to the participating center's regular protocol, as this is purely an observational and non-interventional study. Further data collection on outcomes (organ function, ventilation duration, length of stay, and survival) will be collected at 72h, 96 h, and at hospital discharge.
详细描述
This is a prospective observational study with no intervention. Study sites have been selected to include wide cross-representation of resuscitation practices using crystalloids alone, crystalloid plus albumin, and among sites that use albumin, variable approaches to the timing of albumin initiation.
Detailed data will be continuously collected in "real time" during fluid resuscitation over the 1st 48 hours following a burn injury. Data collection during this phase will be done prospectively, hour-by-hour, by the bedside nurse caring for the patient. Primarily this data collection will involve recording of resuscitation fluid volumes, urinary output, vital signs (heart rate and blood pressure), and use of vasopressors and inotropes. Outcome data (organ function, need for mechanical ventilation, hospital length of stay, and survival) will be collected at various time points during the subjects' acute care stay.
At completion of the study we intend to make the following comparisons:
- Subjects that received crystalloids only compared to subjects that received crystalloids plus albumin.
- Subjects that had albumin started "early" (< 8 hours post burn), compared to subjects that had albumin started "intermediate" (8-12 hours post burn), compared to subjects that had albumin started "late" (>12 hours post burn).
- Characteristics of resuscitation prior to the start of albumin ("pre-albumin") compared to characteristics of resuscitation following initiation of albumin ("post albumin").
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥ 20% TBSA burns
- •Admitted to the burn center ≤ 12 post injury
排除标准
- •Significant associated trauma
- •High voltage (≥ 1000 volts) electrical burns
- •Surgery anticipated within 48 hours from injury
- •Fresh frozen plasma (FFP) anticipated to be given at any time ≤ 48 hours from injury
- •Hypertonic saline (HTS) anticipated to be given at any time ≤ 48 hours from injury
- •Hydroxyethyl starch (HES) anticipated to be given at any time ≤ 48 hours from injury
- •High dose Vitamin C infusion is anticipated to be given at any time ≤ 48 hours from injury
- •Death occurs or comfort measures are instituted within ≤ 48 hours from injury
结局指标
主要结局
Fluid resuscitation volume
时间窗: 48 hours post burn injury
Total fluid resuscitation volume in mL/kg/% TBSA burn
albumin : crystalloid ratio
时间窗: 48 hours post burn injury
albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid)
次要结局
- Doses of vasopressors and inotropes(48 hours post burn injury)
- completion of resuscitation(up to 48 hours post burn injury)
- Fasciotomy(during the first 48 hours post burn injury)
- abdominal compartment syndrome(during the first 48 hours post burn injury)
- SOFA score (sequential organ failure assessment)(24 hours post burn injury)
- AKIN Score (acute kidney injury network)(24 hours post burn injury)
- AKIN Score(96 hours post burn injury)
- I/O Ratio(48 hours post burn injury)
- SOFA score(96 hours post burn injury)
- Mechanical Ventilation(from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months)
- Hospital Stay(from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months)
- Survival(28 days post burn injury or death, whichever occurs first)