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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 Navigatorâ„¢-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.
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 Navigatorâ„¢, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkland Arm | Active Comparator | 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 Navigatorâ„¢-guided resuscitation. |
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| Burn Navigator Arm | Experimental | Participants in this arm will receive fluid resuscitation guided by the Burn Navigatorâ„¢ 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Burn Navigator | Device | Participants in this arm will receive fluid resuscitation guided by the Burn Navigatorâ„¢ 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 30 day mortality | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALNAS Hospital | Cairo | Egypt |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012151 | Resuscitation |
| C485123 | HES 130-0.4 |
| ID | Term |
|---|---|
| D004638 | Emergency Treatment |
| D013812 | Therapeutics |
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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 Navigatorâ„¢ 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.
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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 Navigatorâ„¢-guided regimen; however, participants will not be informed of which fluid management strategy they receive.
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| Resuscitation (Voluven) | Other | Resuscitation ringer / Resuscitation (Voluven) + Plasma |
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| 24 Hours |