RecruitingNCT06670248

Evaluation of Endothelial Glycocalyx in the Surgical Resuscitation of Major Burn Patients

GlycoBURN Study: Determination of Endothelial Glycocalyx Status in the Surgical Resuscitation of Severe Burn Patients

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrollment

40 participants

Start Date

Mar 5, 2024

Study Type

OBSERVATIONAL

Conditions

Postoperative Complications Hemorrhagic Shock Severe Burn Syndecan 1 Endotheliopathy of Trauma Endothelial Glycocalyx

Summary

The purpose of this observational study is to examine whether Endotheliopathy of Trauma (EoT) is present in severely burned patients and how it is affected by burn debridement surgery. The main questions it aims to answer are: * Do severely burned patients present with EoT before undergoing burn debridement surgery? * Does the surgical intervention worsen EoT, leading to increased postoperative syndecan 1 (sdc 1) levels compared to preoperative levels? Participants will: * Undergo debridement surgery where the total area of debrided and donor sites covers 20% or more of the Total Body Surface Area (TBSA). * Have their sdc 1 levels measured before and after surgery. * Have perioperative factors analyzed to assess their impact on endothelial damage and glycocalyx functionality. This study aims to provide insight into how surgical resuscitation affects the endothelial glycocalyx in severely burned patients.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

Patients over 18 years old with burned TBSA greater than or equal to 20%.
Patients who will undergo debridement of at least 20% of the burned TBSA (including the debrided area and the donor site).

Exclusion Criteria10

Under 18 years old.
Pregnant women.
Patient refusal.
Polytraumatized patients.
Electrical or chemical burns.
Patients with any of the following pre-burn conditions: complicated heart disease\*, renal disease on hemodialysis/hemofiltration or with Glomerular Filtration Rate (GFR) \< 30 ml/min/1.73m², and liver cirrhosis (Child A, B, and C).
(\* Definition of complicated heart disease: decompensated heart failure (NYHA class IV), Left Ventricular Ejection Fractio \< 40%, or severe valvular disease).
Patients with a history of chronic inflammatory diseases (autoimmune disease).
Patients on chronic treatment with corticosteroids or immunosuppressants.
Patients requiring reintervention for debridement surgery who have already been included in the study during their first surgery.

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Interventions

PROCEDUREDebridement Surgery

Surgical debridement of burn wounds involving ≥ 20% of the TBSA, including debrided and donor sites.

DIAGNOSTIC_TESTSdc-1 Level Measurement

Measurement of plasma sdc-1 levels in different situations to assess endothelial glycocalyx damage using an enzyme-linked immunosorbent assay (ELISA): Preoperatively: * Upon admission to the Burn Unit. * 24 hours after admission to the Burn Unit. * Prior to the start of surgery, after anesthetic induction. * If surgery is performed after the fifth day following the burn, an additional sdc-1 measurement will be taken on the fifth day of hospital admission. Postoperatively: * 6 hours after surgery. * 24 hours after surgery. * 48 hours after surgery.