Albumin and Prognosis of Severely Patients Burns (ALBUBURN)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Severe Burn

Study type: Observational

Funder types: Other

Identifiers

NCT04264065

TPS1122427

Details and patient eligibility

About

Hemodynamic management has long been identified as a key factor affecting burn prognosis. However, large amounts of crystalloid infusion have been associated with the development or aggravation of organ failure (acute respiratory distress syndrome, vascular injury, acute renal failure, and intra-abdominal hypertension) which worsens the final prognosis.

The use of albumin during the first 24 hours of burn resuscitation is controversial since capillary leakage may cause transcapillary passage of large molecules into the interstitial space. In fact, human albumin has multiple physiological effects, including regulation of colloidal osmotic pressure, antioxidant properties, nitric oxide modulation and buffering capacities, plasma binding and transport of various substances, which may be particularly important in severe burns.

Currently available data suggest that administration of exogenous albumin during the first 24 hours of resuscitation of severe burn patients may be associated with improved outcomes. Multi-centre randomized controlled trials with adequate power should be undertaken in burned patients.

Full description

In the participating centers: severe burn adult patients with a TBSA burn >30% will be included and followed for 90 days after admission. This observational study will allow us to collect and analyze data in order to design a quality interventional trial evaluating the value of albumin in the initial management of the severely burned patient.

The primary objective of the study is to describe the incidence of a combined endpoint of mortality, severe acute renal failure (stage 3) and severe acute respiratory distress syndrome in severely burned patients.

Secondary Objectives

1. Describe the prognosis of patients with severe burns, with particular emphasis on the impact of albumin on the prognosis of patients with severe burns.
2. Describe how albumin is administered (i.e. doses, duration of treatment, continuous vs. bolus administration, hyperoncotic vs. hypooncotic solutions, etc.).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age
• Burns > 30% SCT
• Patients admitted to the ICU within 12 hours of a burn.

Exclusion criteria

• Pregnancy
• Patients with a limitation of active therapeutics on admission to BICU
• Pre-hospital cardiac arrest
• Moribund patients: pre-hospital cardiac arrest, CBS burn >95%.
• Age >80 years