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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Resuscitation, Burn
• Intervention / Treatment: Other: Resuscitation (Voluven); Device: Burn Navigator

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.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • ALNAS Hospital
    • Contact: Rania Hassan Head of Burn ICU, M.D.; Phone Number: 00201223652233; Email: rania.hassan@aljoud-ngo.com
    • Contact: Yasmin Elsobky Senior Research Specialist, PhDc; Phone Number: 16441 00201224288425; Email: yasmin.elsobky@aljoud-ngo.com
    • Principal Investigator: Rania Hassan, MD
    • Sub-Investigator: Mona mahmoud Zaki, M.D.
    • Sub-Investigator: Mostafa Moharam, M.D.
    • Sub-Investigator: Abdelrahman Fares, M.D.
    • Sub-Investigator: Mohamed Sabry Abdelbadea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Parkland Arm; Participants in this arm will receive fluid resuscitation according to the conventional Parkland formula, which recommends 4 mL/kg/TBSA of crystalloid fluids during the first 24 hours post-burn. Half of the calculated volume will be administered in the first 8 hours after injury, with the remainder given over the next 16 hours. Adjustments may be made based on clinical response, including urine output and hemodynamic status. This approach represents the standard of care for initial burn resuscitation and will be used as the comparator for evaluating the effectiveness of Burn Navigator™-guided resuscitation.	Other: Resuscitation (Voluven); Resuscitation ringer / Resuscitation (Voluven) + Plasma
Experimental: Burn Navigator Arm; 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.	Device: Burn 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total fluid volume administered within the first 24 hours normalized to body weight and %TBSA	Total fluid volume administered within the first 24 hours normalized to body weight and %TBSA	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to target urine output (in hours)	Time to target urine output (in hours)	48hours
Fluid creep occurrence (>6 ml/kg/%TBSA in first 24 hours )	Pulmonary edema Abdominal or extremity compartment syndrome Shock	24 Hours

Other Outcome Measures

Outcome Measure	Time Frame
30 day mortality	30 days

Collaborators and Investigators

• Sponsor: Alnas Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: critically ill; resuscitation; Burn; Severe burn; burn, 2nd degree; burn, 3rd degree; Golden hours
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness; Burns; Therapeutics; Emergency Treatment; Resuscitation; HES 130-0.4
• Other Study ID Numbers: RHDIRB-NA-240823-01UC-NPO-N020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No