Evaluation of Endothelial Glycocalyx in the Surgical Resuscitation of Major Burn Patients (GlycoBURN)

October 30, 2024 updated by: Hospital Universitari Vall d'Hebron Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Laura Pons Pellicé MD, Medical Degree

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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).

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Severe burn patients
Adult severely burned patients (TBSA ≥ 20%) undergoing debridement surgery.
Procedure: Debridement Surgery
Surgical debridement of burn wounds involving ≥ 20% of the TBSA, including debrided and donor sites.
Diagnostic test: Sdc-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sdc-1 perioperative changes
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.
From admission to our Burn Unit until 48 hours post-debridement surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: A) Immediate complications: 24 hours postoperatively; B) Early complications: 7 days postoperatively; C) Late complications: 30 days postoperatively
  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).
A) Immediate complications: 24 hours postoperatively; B) Early complications: 7 days postoperatively; C) Late complications: 30 days postoperatively
Fluid and transfusion requirements
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.
During the surgical procedure and the first 48 hours postoperatively.
Coagulation abnormalities (preoperative and postoperative)
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
Preoperative (from admission to surgery) and postoperative (up to 48 hours after surgery).
Duration of Mechanical Ventilation
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
From the end of surgery until extubation, assessed over a period of up to 180 days.
Length of Stay in the Intensive Care Unit (ICU)
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
From admission to the ICU, after de debridement surgery, until discharge from the ICU (assessed over a period of up to 180 days).
Survival of severely burned patients after debridement surgery
Time Frame: From surgery until 180 days postoperatively.
Survival from surgery until 180 days postoperatively.
From surgery until 180 days postoperatively.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inhalation injury
Time Frame: At admission
Incidence of inhalation injury in severely burned patients
At admission
Preoperative complications
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Estimated)

November 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AT)400/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data that will be shared include:

  • Demographic data (e.g., age, sex, weight, height,)
  • Clinical data (e.g., medical history, burn characteristics, TBSA, type of burn)
  • Outcome measures (e.g., syndecan-1 levels, postoperative complications, survival rates)

IPD Sharing Time Frame

The IPD and supporting information will be available starting 6 months after the final study results are published and will remain available for 5 years.

IPD Sharing Access Criteria

Qualified researchers affiliated with academic, medical, or scientific institutions will be able to access the IPD and supporting information. They will be able to access de-identified individual participant data, including demographic information, clinical data, and outcome measures. Researchers can request access to the data by submitting a data-sharing proposal to Vall d'Hebron University Hospital and signing a data use agreement. Requests will be evaluated on a case-by-case basis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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