Albumin and Prognosis of Severely Patients Burns

Severe Burn Clinical Trial

— ALBUBURN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04264065
• Other study ID #: TPS1122427
• Status: Recruiting
• Start date: September 16, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: François Dr DEPRET, MD
• Phone: (1)42 49 95 70
• Email: francois.depret[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Severe Burn

Locations

Country	Name	City	State
France	Hopital saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of patients with acute renal failure on days 28 and 90	Kidney disease improving global outcome (KDIGO) definition	days 28 and 90 of burn injury
Secondary	Rate of patients with Acute respiratory distress syndrome (ARDS) on days 28 and 90	Berlin Definition	days 28 and 90 of burn injury
Secondary	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	days 28 and 90 of burn injury
Secondary	Rate of patients with Sepsis and septic shock	Definition of Sepsis 3	Days 28 and 90
Secondary	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.	between Day 1 and Day 7