Inhalation Injury Is Associated With Endotheliopathy and Abnormal Fibrinolytic Phenotypes in Burn Patients: A Cohort Study.
John W Keyloun, Tuan D Le, Kathleen E Brummel-Ziedins...
https://pubmed.ncbi.nlm.nih.gov/34089618Actively Recruiting
Age: 18Years +
All Genders
ID06670248
GlycoBURN Study: Evaluating Endothelial Glycocalyx Status in Surgical Resuscitation of Severe Burn Patients
Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2024-11-01
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the presence and impact of Endotheliopathy of Trauma (EoT) in patients with severe burns undergoing surgical resuscitation. The study focuses on whether EoT exists before burn debridement surgery and if the surgery worsens endothelial damage, as indicated by changes in syndecan 1 (sdc 1) levels. EoT is linked to complications such as increased transfusion needs, longer hospital stays, and higher risks of serious health problems. Participants will undergo burn debridement surgery where at least 20% of their total body surface area (TBSA) is treated, including both the burned and donor sites. The study involves measuring plasma sdc 1 levels at multiple time points before and after surgery to assess the condition of the endothelial glycocalyx, a protective layer in blood vessels. Researchers will also analyze perioperative factors that may influence endothelial damage and report on postoperative complications and treatment requirements. During the study, participants will have their sdc 1 levels measured upon admission, before surgery, and at several intervals after surgery up to 48 hours. Researchers will track outcomes such as postoperative complications, fluid and blood product use, coagulation issues, duration of mechanical ventilation, ICU stay length, and survival up to 180 days post-surgery. This observational study will provide detailed insights into how surgical resuscitation affects vascular health in severe burn patients and may inform future strategies to reduce complications.
CONDITIONS
Brief Title
Evaluation of Endothelial Glycocalyx in the Surgical Resuscitation of Major Burn Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old with burned total body surface area (TBSA) of 20% or more
- Patients scheduled for burn debridement surgery involving at least 20% of the burned TBSA, including donor sites
You will not qualify if you...
- Under 18 years old
- Pregnant women
- Patients who refuse to participate
- Patients with multiple traumatic injuries
- Patients with electrical or chemical burns
- Patients with complicated heart disease (decompensated heart failure, severe valvular disease, or low heart function)
- Patients with severe kidney disease requiring dialysis or with very low kidney function
- Patients with liver cirrhosis (any severity)
- Patients with chronic inflammatory or autoimmune diseases
- Patients on long-term corticosteroids or immunosuppressants
- Patients needing repeat burn debridement surgery who already participated in this study during their first surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - From admission until the start of surgery (up to 5 days)
Participants have plasma sdc-1 levels measured before surgery to assess endothelial glycocalyx damage.
4 to 5 blood draws before surgery, including upon admission, 24 hours after admission, prior to surgery after anesthetic induction, and possibly on the fifth day of admission if surgery occurs later
Surgery and Immediate Post-operative Care
Duration - Surgery day and first 48 hours postoperatively
Participants undergo burn debridement surgery and receive surgical resuscitation with monitoring of fluid and blood product administration.
Blood draws and assessments during surgery and at 6, 24, and 48 hours after surgery
Post-operative Follow-up
Duration - Up to 180 days after surgery
Participants are monitored for postoperative complications, duration of mechanical ventilation, ICU stay, and survival up to 180 days after surgery.
Follow-up visits to assess complications at 24 hours, 7 days, 30 days, and ongoing monitoring up to 180 days
Trial Site Locations
Total: 1 location
1
Hospital Universitari Vall d'Hebron
Barcelona, Spain, Spain, 08035
Actively Recruiting
Loading map...
Research Team
L
Laura Pons Pellicé, MD
L
Luis Abarca Vilchez, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Circulating Syndecan-1 and Tissue Factor Pathway Inhibitor, Biomarkers of Endothelial Dysfunction, Predict Mortality in Burn Patients.
John W Keyloun, Tuan D Le, Anthony E Pusateri...
https://pubmed.ncbi.nlm.nih.gov/33394974Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures.
Ib Jammer, Nadine Wickboldt, Michael Sander...
https://pubmed.ncbi.nlm.nih.gov/25058504Shedding of the endothelial glycocalyx is quantitatively proportional to burn injury severity.
J N Luker, M Vigiola Cruz, B C Carney...
https://pubmed.ncbi.nlm.nih.gov/30174566Glycocalyx Shedding is Enhanced by Age and Correlates with Increased Fluid Requirement in Patients with Major Burns.
Akinori Osuka, Hirofumi Kusuki, Kazuhiro Yoneda...
https://pubmed.ncbi.nlm.nih.gov/29023362Endothelial glycocalyx shedding in patients with burns.
Harald Welling, Hanne Hee Henriksen, Erika R Gonzalez-Rodriguez...
https://pubmed.ncbi.nlm.nih.gov/31866179Syndecan-1: A Quantitative Marker for the Endotheliopathy of Trauma.
Erika Gonzalez Rodriguez, Sisse R Ostrowski, Jessica C Cardenas...
https://pubmed.ncbi.nlm.nih.gov/28579548Shock induced endotheliopathy (SHINE) in acute critical illness - a unifying pathophysiologic mechanism.
Pär Ingemar Johansson, Jakob Stensballe, Sisse Rye Ostrowski
https://pubmed.ncbi.nlm.nih.gov/28179016Influence of burn severity on endothelial glycocalyx shedding following thermal trauma: A prospective observational study.
C Tapking, J F Hernekamp, J Horter...
https://pubmed.ncbi.nlm.nih.gov/32839038Hemorrhagic Shock and Resuscitation Causes Glycocalyx Shedding and Endothelial Oxidative Stress Preferentially in the Lung and Intestinal Vasculature.
Sarah Abdullah, Mardeen Karim, Mark Legendre...
https://pubmed.ncbi.nlm.nih.gov/34259440