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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitari Vall d'Hebron Research Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Under 18 years old.

Pregnant women.

Patient refusal.

Polytraumatized patients.

Trial population

Patients admitted to the Burn Unit of Vall d'Hebron University Hospital with burned TBSA ≥ 20% who undergo debridement surgery (total area between the debrided and donor sites ≥ 20% of TBSA).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Debridement Surgery

    Procedure/Surgery

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

  • Sdc-1 Level Measurement

    Diagnostic test

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Severe burn patients2 interventions

Trial outcomes

Primary outcomes

1

Sdc-1 perioperative changes

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
From admission to our Burn Unit until 48 hours post-debridement surgery.

Secondary outcomes

1

Postoperative complications

1. Cardiovascular complications (yes/no): new-onset atrial fibrillation or other arrhythmias, presence of non-fatal cardiopulmonary arrest, acute myocardial infarction, acute pulmonary edema, and myocardial injury after non-cardiac surgery (MINS). 2. Pulmonary complications (yes/no): pneumonia, whether associated with mechanical ventilation or not, pleural effusion, acute respiratory distress syndrome (ARDS), pneumothorax, bronchospasm, and the need for tracheostomy. 3. Renal failure (yes/no): need for dialysis or hemofiltration (yes/no). 4. Abdominal compartment syndrome (yes/no). 5. Thrombotic complications (yes/no): lower limb thrombosis, pulmonary embolism, and cerebrovascular accident. (The following publication is used as a reference for the definition of complications: DOI: 10.1097/EJA.0000000000000118).

Time frame
A) Immediate complications: 24 hours postoperatively; B) Early complications: 7 days postoperatively; C) Late complications: 30 days postoperatively
2

Fluid and transfusion requirements

Volume of fluids and blood products transfused during surgery and in the postoperative period.

Time frame
During the surgical procedure and the first 48 hours postoperatively.
3

Coagulation abnormalities (preoperative and postoperative)

Analysis of the coagulation abnormalities (guided by classic coagulation tests and thromboelastometry parameters) resulting from burn debridement surgery

Time frame
Preoperative (from admission to surgery) and postoperative (up to 48 hours after surgery).
4

Duration of Mechanical Ventilation

Number of days on mechanical ventilation after debridement surgery

Time frame
From the end of surgery until extubation, assessed over a period of up to 180 days.

Other outcomes

1

Inhalation injury

Incidence of inhalation injury in severely burned patients

Time frame
At admission
2

Preoperative complications

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.

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.