Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Location status: Recruiting
Location contact
Laura Pons Pellicé MD, Medical Degree
CONTACT
NCT Number: NCT06670248
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Barcelona, Spain, 08035
Location status: Recruiting
Laura Pons Pellicé MD, Medical Degree
CONTACT
The endothelial glycocalyx is a protective layer of glycoproteins, glycosaminoglycans, and proteoglycans that lines the luminal surface of blood vessels and plays a critical role in regulating vascular permeability and coagulation. The syndecan family, consisting of four members (syndecan 1-4), is the main proteoglycan. Of particular interest, sdc 1 is a marker of endothelial damage, with elevated levels (>40 ng/ml) being linked to EoT. This condition is characterized by increased transfusion requirements, prolonged hospital stays, and higher morbidity and mortality rates.
Early burn debridement (from the fifth day onward) has been associated with improved outcomes in severely burned patients. The purpose of this surgical intervention is to mitigate the inflammatory response triggered by the burned (and potentially infected) skin. However, this surgery presents significant challenges for anesthesiologists, as it typically involves massive blood loss and may exacerbate the shock that these patients frequently experience. To counteract hemorrhagic shock induced by the surgical trauma, fluid and blood product administration is critical. The state of the endothelial glycocalyx may influence the effectiveness of surgical resuscitation. When damaged, the glycocalyx heightens the risk of postoperative pulmonary edema, prolonged mechanical ventilation, abdominal or limb compartment syndrome, and deepened burns due to poor perfusion. These complications increase the likelihood of sepsis, multi-organ failure, and elevated mortality.
This study aims to evaluate whether EoT is present in severely burned patients before surgery and assess whether the surgical intervention exacerbates this condition. Investigators will conduct a two-year prospective observational cohort study at the Burn Unit of Vall d'Hebron University Hospital, from March 2024 to March 2026. The study will include patients undergoing burn debridement surgery involving 20% or more of their TBSA. Plasma sdc 1 levels will be measured preoperatively and postoperatively to assess glycocalyx disruption. Additionally, investigators will analyze perioperative factors to determine their relationship with endothelial damage.
The literature on severely burned patients and the endothelial glycocalyx is limited, with no studies to date specifically addressing its role in surgical resuscitation. Quantifying perioperative sdc 1 levels will help provide a clearer understanding of the status and function of the glycocalyx in these patients. This insight could contribute to strategies aimed at protecting the endothelial glycocalyx, potentially reducing postoperative complications related to fluid therapy and positively impacting the morbidity and mortality of severely burned patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(* Definition of complicated heart disease: decompensated heart failure (NYHA class IV), Left Ventricular Ejection Fractio < 40%, or severe valvular disease).
Surgical debridement of burn wounds involving ≥ 20% of the TBSA, including debrided and donor sites.
Measurement of plasma sdc-1 levels in different situations to assess endothelial glycocalyx damage using an enzyme-linked immunosorbent assay (ELISA):
Preoperatively:
Postoperatively:
Time frame: From admission to our Burn Unit until 48 hours post-debridement surgery.
Sdc-1 levels will be measured upon admission to our Burn Unit, 24 hours after admission, on the 5th day of admission if surgery has not yet been performed, immediately before debridement surgery, and during the first 48 hours postoperatively.
Time frame: A) Immediate complications: 24 hours postoperatively; B) Early complications: 7 days postoperatively; C) Late complications: 30 days postoperatively
(The following publication is used as a reference for the definition of complications: DOI: 10.1097/EJA.0000000000000118).
Time frame: During the surgical procedure and the first 48 hours postoperatively.
Volume of fluids and blood products transfused during surgery and in the postoperative period.
Time frame: Preoperative (from admission to surgery) and postoperative (up to 48 hours after surgery).
Analysis of the coagulation abnormalities (guided by classic coagulation tests and thromboelastometry parameters) resulting from burn debridement surgery
Time frame: From the end of surgery until extubation, assessed over a period of up to 180 days.
Number of days on mechanical ventilation after debridement surgery
Time frame: From admission to the ICU, after de debridement surgery, until discharge from the ICU (assessed over a period of up to 180 days).
Number of days of ICU stay
Time frame: From surgery until 180 days postoperatively.
Survival from surgery until 180 days postoperatively.
Time frame: At admission
Incidence of inhalation injury in severely burned patients
Time frame: From admission to the Burn Unit until the day of the first debridement surgery, assessed over a period of up to 30 days following admission.
Incidence of pre-surgical complications including: pulmonary infection, urinary tract infection, renal dysfunction, skin infection, shock, pulmonary distress, ischemic heart disease, atrial fibrillation, thrombotic or hemorrhagic stroke.
Contact information is provided by the study sponsor or research team.
Laura Pons Pellicé, MD
CONTACT
Luis Abarca Vilchez, MD, PhD
CONTACT
Hospital Universitari Vall d'Hebron Research Institute
Other
GlycoBURN Study: Determination of Endothelial Glycocalyx Status in the Surgical Resuscitation of Severe Burn Patients
Acronym: GlycoBURN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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