Severe Burn
Conditions
Keywords
Severe Burn, acute respiratory distress, acute kidney injury, Albumin
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.).
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with acute renal failure on days 28 and 90 | days 28 and 90 of burn injury | Kidney disease improving global outcome (KDIGO) definition |
| Rate of patients with Acute respiratory distress syndrome (ARDS) on days 28 and 90 | days 28 and 90 of burn injury | Berlin Definition |
| Rate of patients with Acute Abdominal Compartment Syndrome | days 28 and 90 of burn injury | ACS is defined as sustained AIP \> 20 mmHg associated with new or ongoing organ dysfunction or failure |
| Rate of patients with Sepsis and septic shock | Days 28 and 90 | Definition of Sepsis 3 |
| SOFA Score | 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. |
Countries
France
Contacts
Primary ContactFrançois Dr DEPRET, MD
Backup ContactMatthieu Pr LEGRAND, MD-PhD
Outcome results
None listed