NCT04264065

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Sep 2022Jan 2027

First Submitted

Initial submission to the registry

February 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
2.6 years until next milestone

Study Start

First participant enrolled

September 16, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2027

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

4.3 years

First QC Date

February 7, 2020

Last Update Submit

January 13, 2026

Conditions

Severe Burn

Keywords

Severe Burnacute respiratory distressacute kidney injuryAlbumin

Outcome Measures

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.

    28 days of burn injury

Secondary Outcomes (5)

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

    days 28 and 90 of burn injury

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

    days 28 and 90 of burn injury

  • Rate of patients with Acute Abdominal Compartment Syndrome

    days 28 and 90 of burn injury

  • Rate of patients with Sepsis and septic shock

    Days 28 and 90

  • SOFA Score

    between Day 1 and Day 7

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital saint Louis

Paris, France, 75010, France

RECRUITING

Related Publications (7)

  • 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.

    PMID: 17137702BACKGROUND

  • 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.

    PMID: 27828823BACKGROUND

  • 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.

    PMID: 29561390BACKGROUND

  • 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.

    PMID: 17414612BACKGROUND

  • 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.

    PMID: 19476867BACKGROUND

  • 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.

    PMID: 16398734BACKGROUND

  • 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.

    PMID: 17223485BACKGROUND

MeSH Terms

Conditions

BurnsAcute Lung InjuryAcute Kidney Injury

Condition Hierarchy (Ancestors)

Wounds and InjuriesLung InjuryLung DiseasesRespiratory Tract DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • François Dr DEPRET, MD

    Hospital Saint Louis (AP-HP)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

François Dr DEPRET, MD

CONTACT

(1)42 49 95 70francois.depret@aphp.fr

Matthieu Pr LEGRAND, MD-PhD

CONTACT

(1)42 49 95 70matthieu.m.legrand@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 11, 2020

Study Start

September 16, 2022

Primary Completion (Estimated)

January 16, 2027

Study Completion (Estimated)

January 16, 2027

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

FR(1)