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

NCT ID: NCT07307599

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-12-31

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.

Conditions

Resuscitation, Burn

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Resuscitation (Voluven)

Intervention Type: OTHER

Resuscitation ringer / Resuscitation (Voluven) + Plasma

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.

Group Type: EXPERIMENTAL

Burn Navigator

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Resuscitation (Voluven)

Resuscitation ringer / Resuscitation (Voluven) + Plasma

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alnas Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rania Hassan Abdel hafiez

Head of Burn ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ALNAS Hospital

Cairo, , Egypt

Countries

Egypt

Facility Contacts

Rania Hassan Head of Burn ICU, M.D.

Role: primary

Yasmin Elsobky Senior Research Specialist, PhDc

Role: backup

Other Identifiers

RHDIRB-NA-240823-01UC-NPO-N020

Identifier Type: -

Identifier Source: org_study_id