Evaluation of Endothelial Glycocalyx in the Surgical Resuscitation of Major Burn Patients (NCT06670248) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Endothelial Glycocalyx in the Surgical Resuscitation of Major Burn Patients
Spain40 participantsStarted 2024-03-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sdc-1 perioperative changes
Timeframe: From admission to our Burn Unit until 48 hours post-debridement surgery.
Trial details
NCT IDNCT06670248
SponsorHospital Universitari Vall d'Hebron Research Institute