Albumin and Prognosis of Severely Patients Burns
ConditionSevere Burn
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 18 years of age
Burns > 30% SCT
Patients admitted to the ICU within 12 hours of a burn.
Disqualifiers
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%.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
28 days of burn injurySecondary outcomes
1
Rate of patients with acute renal failure on days 28 and 90
Kidney disease improving global outcome (KDIGO) definition
Time frame
days 28 and 90 of burn injury2
Rate of patients with Acute respiratory distress syndrome (ARDS) on days 28 and 90
Berlin Definition
Time frame
days 28 and 90 of burn injury3
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
Time frame
days 28 and 90 of burn injury4
Rate of patients with Sepsis and septic shock
Definition of Sepsis 3
Time frame
Days 28 and 90Sponsors and contacts
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Source ClinicalTrials.gov