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

NCT06670248 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-11-01

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2026-03-31
Completion
2026-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06670248 on ClinicalTrials.gov