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

NCT07307599 | Not Yet Recruiting Phase 4

• 1 other identifier: RHDIRB-NA-240823-01UC-NPO-N020
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Resuscitation, Burn

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to target urine output (in hours)

  48hours

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

  24 Hours

Other Outcomes (1)

• 30 day mortality

  30 days

Study Arms (2)

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 Navigator™-guided resuscitation.

Other: Resuscitation (Voluven)

Burn Navigator Arm

EXPERIMENTAL

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

Interventions

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.

Burn Navigator Arm

Resuscitation (Voluven) OTHER

Resuscitation ringer / Resuscitation (Voluven) + Plasma

Parkland Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alnas Hospital: lead

Study Sites (1)

ALNAS Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Burns; Critical Illness

Interventions

Resuscitation; HES 130-0.4

Condition Hierarchy (Ancestors)

Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Emergency Treatment; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Burn ICU

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

EG (1)