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NCT Number: NCT07307599

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ALNAS Hospital

Cairo, Egypt

Location contact

Abdelrahman Fares, M.D.

SUB_INVESTIGATOR

Mohamed Sabry Abdelbadea

SUB_INVESTIGATOR

Mona mahmoud Zaki, M.D.

SUB_INVESTIGATOR

Mostafa Moharam, M.D.

SUB_INVESTIGATOR

Rania Hassan Head of Burn ICU, M.D.

CONTACT

[email protected]

00201223652233

Rania Hassan, MD

PRINCIPAL_INVESTIGATOR

Yasmin Elsobky Senior Research Specialist, PhDc

CONTACT

[email protected]

00201224288425 ext. 16441

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Burn Navigator

Device

Participants in this arm will receive fluid resuscitation guided by the Burn Navigator™ decision-support system. This software uses real-time mathematical modeling based on weight, burn size, time post-injury, prior fluid infusion, and the last three urine output measurements to generate hourly recommended fluid rates. The goal is to optimize resuscitation, avoid over- or under-resuscitation, and maintain adequate end-organ perfusion during the first 48-72 hours post-burn. Clinical teams will follow the system's recommendations unless medically contraindicated.

Resuscitation (Voluven)

Other

Resuscitation ringer / Resuscitation (Voluven) + Plasma

Primary outcomes

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

    Time frame: 24 hours

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

Secondary outcomes

  1. Time to target urine output (in hours)

    Time frame: 48hours

    Time to target urine output (in hours)

  2. Fluid creep occurrence (>6 ml/kg/%TBSA in first 24 hours )

    Time frame: 24 Hours

    Pulmonary edema Abdominal or extremity compartment syndrome Shock

Other outcomes

  1. 30 day mortality

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Alnas Hospital

Other

Registry information

Acronym: FLARE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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