Clinical trial NCT04264065: Albumin and Prognosis of Severely Patients Burns
Official title: Albumin and Prognosis of Severely Burned Patients Prospective, Observational Study for the BurnICU Group of ESICM
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Burn
Keywords: Severe Burn
acute respiratory distress
acute kidney injury
Albumin
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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.).

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 28 days of burn injury
Secondary outcomes:
measure: Rate of patients with acute renal failure on days 28 and 90
timeFrame: days 28 and 90 of burn injury
measure: Rate of patients with Acute respiratory distress syndrome (ARDS) on days 28 and 90
timeFrame: days 28 and 90 of burn injury
measure: Rate of patients with Acute Abdominal Compartment Syndrome
timeFrame: days 28 and 90 of burn injury
measure: Rate of patients with Sepsis and septic shock
timeFrame: Days 28 and 90
measure: SOFA Score
timeFrame: between Day 1 and Day 7
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital saint Louis
Study officials:
affiliation: Hospital Saint Louis (AP-HP)
name: François Dr DEPRET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.