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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07307599
Acronym
FLARE
Enrollment
62
Registered
2025-12-29
Start date
2026-01-01
Completion date
2026-12-31
Last updated
2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resuscitation, Burn

Keywords

resuscitation, burn, 2nd degree, burn, 3rd degree, Burn, Severe burn, critically ill, Golden hours

Brief summary

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.

Detailed description

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.

Interventions

DEVICEBurn Navigator

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 ringer / Resuscitation (Voluven) + Plasma

Sponsors

Alnas Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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.

Intervention model description

This study uses a two-group comparative design to evaluate fluid resuscitation strategies in adult burn patients. Participants will be allocated into two parallel groups. The control group will receive fluid resuscitation guided by the standard Parkland formula during the first 48 hours post-burn. The intervention group will receive fluid resuscitation directed by the Burn Navigator™ system, which provides hourly recommendations based on patient-specific variables including urinary output, weight, burn size, and time post-injury. Both groups will be monitored for adequacy of resuscitation, complications of under- or over-resuscitation, and overall clinical outcomes.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total fluid volume administered within the first 24 hours normalized to body weight and %TBSA24 hoursTotal fluid volume administered within the first 24 hours normalized to body weight and %TBSA

Secondary

MeasureTime frameDescription
Fluid creep occurrence (>6 ml/kg/%TBSA in first 24 hours )24 HoursPulmonary edema Abdominal or extremity compartment syndrome Shock
Time to target urine output (in hours)48hoursTime to target urine output (in hours)

Other

MeasureTime frame
30 day mortality30 days

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026