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Severe BurnALBUBURNNCT04264065

Albumin and Prognosis of Severely Patients Burns

An observational study of Severe Burn, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Severe Burn
How many people
200 participants
Where
1 siteFrance
Study dates
16 Sep 2022to 16 Jan 2027
Phase
Observational
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: it is a population of adults burned to more than 30% of total skin surface. In fact, beyond this surface, the investigators expect to observe a large volume of perfused crystalloid and potentially an incidence of the primary endpoint of around 40%. These are the people who could potentially benefit the most from albumin therapy.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

François Dr DEPRET, MD contact

(1)42 49 95 70 ext. +33

francois.depret@aphp.fr

Matthieu Pr LEGRAND, MD-PhD contact

(1)42 49 95 70 ext. +33

matthieu.m.legrand@gmail.com

France1 site, 1 recruiting

  • Hopital saint Louis

    Paris, France, 75010

    François DEPRET, MDPHD, françois.depret@aphp.fr

    Recruiting

Other trials in France

About this study

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

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.

Read the detailed 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.).
Conditions
Severe Burn
Keywords
Severe Burn, acute respiratory distress, acute kidney injury, Albumin
Medical subject headings
Burns, Acute Lung Injury, Acute Kidney Injury

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 28 days of burn injury

Secondary outcomes (5)

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

    Kidney disease improving global outcome (KDIGO) definition

    Measured: days 28 and 90 of burn injury

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

    Berlin Definition

    Measured: days 28 and 90 of burn injury

  3. Rate of patients with Acute Abdominal Compartment Syndrome

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

    Measured: days 28 and 90 of burn injury

  4. Rate of patients with Sepsis and septic shock

    Definition of Sepsis 3

    Measured: Days 28 and 90

  5. SOFA Score

    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.

    Measured: between Day 1 and Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2020
  2. Study start16 Sep 2022
  3. Primary completion16 Jan 2027 (estimated)
  4. Study completion16 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04264065
Sponsor's protocol ID
TPS1122427
Acronym
ALBUBURN
Status last verified
Jan 2026
First submitted
7 Feb 2020
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Arlati S, Storti E, Pradella V, Bucci L, Vitolo A, Pulici M. Decreased fluid volume to reduce organ damage: a new approach to burn shock resuscitation? A preliminary study. Resuscitation. 2007 Mar;72(3):371-8. doi: 10.1016/j.resuscitation.2006.07.010. Epub 2006 Nov 29.

    PubMed 17137702

  • Mason SA, Nathens AB, Finnerty CC, Gamelli RL, Gibran NS, Arnoldo BD, Tompkins RG, Herndon DN, Jeschke MG; Inflammation and the Host Response to Injury Collaborative Research Program.. Hold the Pendulum: Rates of Acute Kidney Injury are Increased in Patients Who Receive Resuscitation Volumes Less than Predicted by the Parkland Equation. Ann Surg. 2016 Dec;264(6):1142-1147. doi: 10.1097/SLA.0000000000001615.

    PubMed 27828823

  • Soussi S, Taccori M, De Tymowski C, Depret F, Chaussard M, Fratani A, Jully M, Cupaciu A, Ferry A, Benyamina M, Serror K, Boccara D, Chaouat M, Mimoun M, Cattan P, Zagdanski AM, Anstey J, Mebazaa A, Legrand M; PRONOBURN group. Risk Factors for Acute Mesenteric Ischemia in Critically Ill Burns Patients-A Matched Case-Control Study. Shock. 2019 Feb;51(2):153-160. doi: 10.1097/SHK.0000000000001140.

    PubMed 29561390

  • Klein MB, Hayden D, Elson C, Nathens AB, Gamelli RL, Gibran NS, Herndon DN, Arnoldo B, Silver G, Schoenfeld D, Tompkins RG. The association between fluid administration and outcome following major burn: a multicenter study. Ann Surg. 2007 Apr;245(4):622-8. doi: 10.1097/01.sla.0000252572.50684.49.

    PubMed 17414612

  • Markell KW, Renz EM, White CE, Albrecht ME, Blackbourne LH, Park MS, Barillo DA, Chung KK, Kozar RA, Minei JP, Cohn SM, Herndon DN, Cancio LC, Holcomb JB, Wolf SE. Abdominal complications after severe burns. J Am Coll Surg. 2009 May;208(5):940-7; discussion 947-9. doi: 10.1016/j.jamcollsurg.2008.12.023. Epub 2009 Mar 26.

    PubMed 19476867

  • Cooper AB, Cohn SM, Zhang HS, Hanna K, Stewart TE, Slutsky AS; ALBUR Investigators. Five percent albumin for adult burn shock resuscitation: lack of effect on daily multiple organ dysfunction score. Transfusion. 2006 Jan;46(1):80-9. doi: 10.1111/j.1537-2995.2005.00667.x.

    PubMed 16398734

  • Cochran A, Morris SE, Edelman LS, Saffle JR. Burn patient characteristics and outcomes following resuscitation with albumin. Burns. 2007 Feb;33(1):25-30. doi: 10.1016/j.burns.2006.10.005.

    PubMed 17223485

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Burn, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 3 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. 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 France. 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.

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?

Contact François Dr DEPRET, MD ((1)42 49 95 70 ext. +33, francois.depret@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04264065, which also lists 7 linked publications.

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 15 Jan 2026.

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