Resuscitation, BurnPhase 4FLARENCT07307599
Optimizing Fluid Resuscitation in Adults With Major Burns: A Randomized Trial of Burn Navigator™ Versus Parkland Formula
A Phase 4 study testing Burn Navigator and Resuscitation (Voluven) in people with Resuscitation, Burn, run by Alnas Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resuscitation, Burn
- What is being tested?
- Burn Navigator and Resuscitation (Voluven)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years old)
- Total Burn Surface Area (TBSA) ≥20%
- weight > 40 kg
- Informed consent provided
Who cannot join
- Primary electrical burn
- Pregnancy
- End-stage renal disease or decompensated heart failure
- Burns associated with trauma (polytrauma)
- Refusal or withdrawal of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
ALNAS Hospital
Cairo
Rania Hassan Head of Burn ICU, M.D., 00201223652233, rania.hassan@aljoud-ngo.com
Yasmin Elsobky Senior Research Specialist, PhDc, 00201224288425 ext. 16441, yasmin.elsobky@aljoud-ngo.com
About this study
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.
Read the 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
- Being tested
- Burn Navigator, Resuscitation (Voluven)
- Keywords
- resuscitation, burn, 2nd degree, burn, 3rd degree, Burn, Severe burn, critically ill, Golden hours
- Medical subject headings
- Burns, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burn NavigatorDevice
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 (Voluven)Other
Resuscitation ringer / Resuscitation (Voluven) + Plasma
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Burn Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (2)
Time to target urine output (in hours)
Time to target urine output (in hours)
Measured: 48hours
Fluid creep occurrence (>6 ml/kg/%TBSA in first 24 hours )
Pulmonary edema Abdominal or extremity compartment syndrome Shock
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resuscitation, BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alnas Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Hassan Abdel hafiez, Alnas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307599
- Sponsor's protocol ID
- RHDIRB-NA-240823-01UC-NPO-N020
- Acronym
- FLARE
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Fluid Resuscitation in Adults With Major Burns: A Randomized Trial of Burn Navigator™ Versus Parkland Formula
- ClinicalTrials.gov ID
- NCT07307599
- Acronym / sponsor ID
- FLARE / RHDIRB-NA-240823-01UC-NPO-N020
- Conditions
- Resuscitation, Burn
- Keywords
- resuscitation, burn, 2nd degree, burn, 3rd degree, Burn, Severe burn, critically ill, Golden hours
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Alnas HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Parkland Arm | Active comparator | Other: Resuscitation (Voluven)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. |
| Burn Navigator Arm | Experimental | Device: Burn NavigatorParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥18 years old)
- Total Burn Surface Area (TBSA) ≥20%
- weight > 40 kg
- Informed consent provided
Key exclusion criteria (5 listed)
- Primary electrical burn
- Pregnancy
- End-stage renal disease or decompensated heart failure
- Burns associated with trauma (polytrauma)
- Refusal or withdrawal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Burn NavigatorParticipants 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 Arm |
| Resuscitation (Voluven)Resuscitation ringer / Resuscitation (Voluven) + Plasma | Other | Parkland Arm |
Primary outcome
Total fluid volume administered within the first 24 hours normalized to body weight and %TBSA
Time frame: 24 hours
Total fluid volume administered within the first 24 hours normalized to body weight and %TBSA
2 secondary outcomes
Time to target urine output (in hours)
Time frame: 48hours
Fluid creep occurrence (>6 ml/kg/%TBSA in first 24 hours )
Time frame: 24 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Burn Navigator and Resuscitation (Voluven) in people with Resuscitation, Burn, run by Alnas Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fluid volume administered within the first 24 hours normalized to body weight and %TBSA (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.