NCT06670248 Evaluation of Endothelial Glycocalyx in the Surgical Resuscitation of Major Burn Patients
| NCT ID | NCT06670248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute |
| Condition | Syndecan 1 |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-03-05 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-03-05 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06670248 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Syndecan 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06670248 currently recruiting?
Yes, NCT06670248 is actively recruiting participants. Contact the research team at laura.pons@vallhebron.cat for enrollment information.
Where is the NCT06670248 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06670248 clinical trial?
NCT06670248 is sponsored by Hospital Universitari Vall d'Hebron Research Institute. The trial plans to enroll 40 participants.