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NCT Number: NCT04264065

Albumin and Prognosis of Severely Patients Burns

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.

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Key information

Conditions

Severe Burn Acute Kidney Injury Acute Lung Injury Burns Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Lung Diseases Lung Injury Male Urogenital Diseases Renal Insufficiency Respiratory Tract Diseases Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital saint Louis

Paris, France, 75010

Location status: Recruiting

Location contact

François DEPRET, MDPHD

CONTACT

franç[email protected]

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The primary endpoint will be a combined endpoint of mortality, stage 3 acute renal failure and severe acute respiratory distress syndrome within 28 days of burn injury.

    Time frame: 28 days of burn injury

Secondary outcomes

  1. Rate of patients with acute renal failure on days 28 and 90

    Time frame: days 28 and 90 of burn injury

    Kidney disease improving global outcome (KDIGO) definition

  2. Rate of patients with Acute respiratory distress syndrome (ARDS) on days 28 and 90

    Time frame: days 28 and 90 of burn injury

    Berlin Definition

  3. Rate of patients with Acute Abdominal Compartment Syndrome

    Time frame: days 28 and 90 of burn injury

    ACS is defined as sustained AIP > 20 mmHg associated with new or ongoing organ dysfunction or failure

  4. Rate of patients with Sepsis and septic shock

    Time frame: Days 28 and 90

    Definition of Sepsis 3

  5. SOFA Score

    Time frame: between Day 1 and Day 7

    Sepsis related organ failure assessment (SOFA) score the minimum value is 0 meaning no organ dysfunction and the maximum being 24 meaning the maximum organs dysfunction.

Study contacts

Contact information is provided by the study sponsor or research team.

François Dr DEPRET, MD

CONTACT

[email protected]

(1)42 49 95 70 ext. +33

Matthieu Pr LEGRAND, MD-PhD

CONTACT

[email protected]

(1)42 49 95 70 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Albumin and Prognosis of Severely Burned Patients Retrospective, Prospective, Observational Study for the BurnICU Group of ESICM

Acronym: ALBUBURN

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2020
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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