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临床试验/NCT07307599
NCT07307599尚未招募4 期

Optimizing Fluid Resuscitation in Adults With Major Burns: A Randomized Trial of Burn Navigator™ Versus Parkland Formula

Alnas Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
Total fluid volume administered within the first 24 hours normalized to body weight and %TBSA

研究概览

简要总结

Burn injuries affecting ≥20% TBSA trigger major fluid shifts requiring aggressive fluid resuscitation to prevent burn shock. Traditional formulas such as the Parkland and Modified Brooke estimate initial 24-hour fluid needs, but both under- and over-resuscitation can cause serious complications. To improve accuracy, the Burn Navigator™ (BN) system uses patient-specific, real-time data and mathematical modeling to guide hourly fluid adjustments. Previous studies showed reduced fluid volumes compared to manual resuscitation, but comprehensive evaluation across settings is lacking.

This study aims to compare Burn Navigator™-guided resuscitation versus the conventional Parkland formula in adult burn patients during the first 24-72 hours post-injury, focusing on achieving optimal fluid balance and preventing complications.

详细描述

Burn injuries vary widely in cause and severity but share the fundamental pathologic feature of liquefactive necrosis of the skin, the body's largest organ and a key component of the immune defense system. When burns involve 20% or more of the total body surface area (TBSA), a profound systemic inflammatory response develops. This response causes extensive fluid shifts and third spacing, leading to loss of intravascular volume, reduced organ perfusion, and a high risk of burn shock. To counter these physiological changes, intravenous fluid resuscitation during the first 24-48 hours post-burn is an essential component of management.

Traditional burn resuscitation guidelines-most notably the Parkland formula (4 mL/kg/TBSA) and the Modified Brooke formula (2 mL/kg/TBSA)-provide initial estimates for required fluid volumes. However, these formulas are static and may not reflect rapid, patient-specific changes. Excessive fluid administration can result in life-threatening complications such as abdominal, extremity, or ocular compartment syndrome, while inadequate resuscitation can precipitate acute kidney injury, burn shock, or multi-organ failure.

Modern approaches emphasize dynamic hourly titration of fluids based on physiologic response, particularly urinary output (UO), to avoid under- and over-resuscitation. To support clinicians in making real-time adjustments, the Burn Resuscitation Decision Support System (BRDSS) was developed by the United States Army Institute of Surgical Research and UTMB. Now commercialized as the Burn Navigator™, this system uses a mathematical model incorporating UO trends, fluid infusion rates, burn size, body weight, and time post-injury to generate hourly fluid recommendations. Studies have shown it can reduce overall fluid exposure compared to manual adjustments.

Despite widespread adoption in military and civilian burn centers, there has been no comprehensive evaluation of its performance across varied clinical environments.

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
Single (Participant)

盲法说明

This study will use a single-blind parallel design in which participants are unaware of the resuscitation method assigned to them. Clinical staff delivering care will know the allocation in order to administer either the Parkland formula or the Burn Navigator™-guided regimen; however, participants will not be informed of which fluid management strategy they receive.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥18 years old)
  • Total Burn Surface Area (TBSA) ≥20%
  • weight > 40 kg
  • Informed consent provided

排除标准

  • Primary electrical burn
  • Pregnancy
  • End-stage renal disease or decompensated heart failure
  • Burns associated with trauma (polytrauma)
  • Refusal or withdrawal of consent

结局指标

主要结局

Total fluid volume administered within the first 24 hours normalized to body weight and %TBSA

时间窗: 24 hours

Total fluid volume administered within the first 24 hours normalized to body weight and %TBSA

次要结局

  • Time to target urine output (in hours)(48hours)
  • Fluid creep occurrence (>6 ml/kg/%TBSA in first 24 hours )(24 Hours)

研究者

发起方
Alnas Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rania Hassan Abdel hafiez

Head of Burn ICU

Alnas Hospital

研究点 (1)

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