What is the mechanism of action of this treatment?

The most common treatments for burns include fluid resuscitation strategies using either colloids (e.g., LR + 5% Albumin) or crystalloids (e.g., LR alone). Colloids like Albumin are larger molecules that remain in the vascular space longer, providing more sustained volume expansion and potentially improving hemodynamic stability. Crystalloids, such as Lactated Ringer's (LR), distribute quickly into the interstitial space, requiring larger volumes to achieve the same effect. Effective fluid resuscitation is crucial for burn patients to prevent hypovolemic shock, maintain adequate tissue perfusion, and support organ function during the acute phase of injury.

What side effects are associated with this type of intervention?

The most common treatments for burns, particularly fluid resuscitation strategies, include colloids (LR + 5% Albumin) and crystalloids (LR alone). Colloids like albumin can cause allergic reactions, fluid overload, and are more expensive. Crystalloids like lactated Ringer's are generally well-tolerated but can lead to electrolyte imbalances, such as hyperchloremic metabolic acidosis, and may require larger volumes to achieve the same hemodynamic effect, potentially increasing the risk of edema.

What prior FDA approvals exist?

The FDA has approved various treatments for burn management, focusing on fluid resuscitation strategies to maintain hemodynamic stability. Colloids such as 5% albumin and crystalloids like lactated Ringer's (LR) solution are commonly used. Albumin, a larger molecule, remains in the vascular space longer, providing sustained volume expansion, while LR, a crystalloid, distributes quickly into the interstitial space. These treatments aim to restore fluid balance and support recovery in burn patients. Specific FDA approvals for these agents include their use in fluid resuscitation protocols for severe burns.

What other types of research exist?

Promising novel alternatives for fluid resuscitation in burn patients include the use of polyglutamic acid polymers as plasma volume expanders, which have demonstrated effective plasma volume retention and oncotic efficiency. Additionally, PASylation technology, which increases the hydrodynamic volume of biopharmaceuticals, could be adapted to enhance plasma half-life and retention, providing more sustained volume expansion compared to traditional colloid and crystalloid strategies.

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Colloid

Albumin Human for Burns (ABRUPT2 Trial)

N/A

Recruiting

Led By David G Greenhalgh, MD

Research Sponsored by American Burn Association

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

There is a plan for formal fluid resuscitation

Must not have

Hypertonic saline (HTS) given at any time ≤ 48 hours from injury

Administration of human albumin prior to randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24, 48, 72, and 96 hours post burn injury

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial compares two ways of giving fluids to adults with severe burns. One way uses a mix of saltwater and protein solutions, while the other uses just saltwater. The goal is to see which way better maintains blood pressure and organ function by replacing lost fluids.

Who is the study for?

Adults with severe burns covering at least 25% of their body, admitted to a burn center within 12 hours of injury and needing fluid resuscitation can join. Excluded are those with major trauma, certain pre-injury conditions like kidney or liver disease, heart dysfunction, pregnancy, or specific treatments received before the trial.

What is being tested?

The study is testing two ways to help adults recover from severe burns by giving fluids. One group gets lactated Ringer's solution plus albumin (a protein), while the other gets just lactated Ringer's. The goal is to see which method works better for resuscitation.

What are the potential side effects?

Albumin may cause allergic reactions, fluid overload leading to swelling or heart problems, and electrolyte imbalances. Lactated Ringer’s might lead to similar issues but without the risks associated with proteins.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a procedure to receive fluids for my condition.

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Over 25% of my body is burned.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I received hypertonic saline within 48 hours of my injury.

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I have received human albumin before being assigned to a treatment group.

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I have stage 3 or higher chronic kidney disease before any injury.

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I have suffered from an electrical burn caused by high voltage.

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I had surgery to remove a burn wound within 2 days of the injury.

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I received a high dose of Vitamin C within 48 hours after getting injured.

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I have a severe liver condition before my injury.

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My heart's pumping ability was weak before my injury.

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I received hydroxyethyl starch within 48 hours of my injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24, 48, 72, and 96 hours post burn injury

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24, 48, 72, and 96 hours post burn injury

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24, 48, 72, and 96 hours post burn injury for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Kidney Failure, Acute

Duration of intubation/mechanical ventilation

Number of crossovers

+10 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: CrystalloidActive Control1 Intervention

Subjects in the crystalloid group will receive fluid resuscitation with Lactated Ringer's titrated each hour to achieve a urine output of 0.5-1mL/kg predicted body weight.

Group II: ColloidActive Control1 Intervention

Subjects in the colloid group will receive fluid resuscitation with Lactated Ringer's and 5% human albumin solution introduced no earlier than 8 hours post burn and no later than 12 hours post burn in a ratio by volume of 1/3 albumin to 2/3 Lactated Ringer's, and titrated each hour to achieve a urine output of 0.5-1mL/kg (milliliter/kilogram) predicted body weight.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for burns include fluid resuscitation strategies using either colloids (e.g., LR + 5% Albumin) or crystalloids (e.g., LR alone). Colloids like Albumin are larger molecules that remain in the vascular space longer, providing more sustained volume expansion and potentially improving hemodynamic stability. Crystalloids, such as Lactated Ringer's (LR), distribute quickly into the interstitial space, requiring larger volumes to achieve the same effect. Effective fluid resuscitation is crucial for burn patients to prevent hypovolemic shock, maintain adequate tissue perfusion, and support organ function during the acute phase of injury.

Healing of partial thickness porcine skin wounds in a liquid environment.A biophysical approach to capillary permeability.Blood-borne collagenous debris complexes with plasma fibronectin after thermal injury.