Syndecan 1GlycoBURNNCT06670248
Evaluation of Endothelial Glycocalyx in the Surgical Resuscitation of Major Burn Patients
An observational study of Syndecan 1 and Severe Burn, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syndecan 1, Severe Burn, Endotheliopathy of Trauma
- What is being tested?
- Debridement Surgery and Sdc-1 Level Measurement
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 5 Mar 2024to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- 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).
Show all 10Show fewer
- ( 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Laura Pons Pellicé MD, Medical Degree
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Syndecan 1, Severe Burn, Endotheliopathy of Trauma, Endothelial Glycocalyx, Hemorrhagic Shock, Postoperative Complications
- Being tested
- Debridement Surgery, Sdc-1 Level Measurement
- Keywords
- Syndecan 1, Endotheliopathy, Glycocalyx, Proteoglycan, Severe burn
- Medical subject headings
- Burns, Shock, Hemorrhagic, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debridement SurgeryProcedure or surgery
Surgical debridement of burn wounds involving ≥ 20% of the TBSA, including debrided and donor sites.
Sdc-1 Level MeasurementDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Severe burn patients | Adult severely burned patients (TBSA ≥ 20%) undergoing debridement surgery. Receives: Procedure: Debridement Surgery; Diagnostic Test: Sdc-1 Level Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sdc-1 perioperative changes
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.
Measured: From admission to our Burn Unit until 48 hours post-debridement surgery.
Secondary outcomes (6)
Postoperative complications
- 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).
- 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.
- Renal failure (yes/no): need for dialysis or hemofiltration (yes/no).
- Abdominal compartment syndrome (yes/no).
- 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).
Measured: A) Immediate complications: 24 hours postoperatively; B) Early complications: 7 days postoperatively; C) Late complications: 30 days postoperatively
Fluid and transfusion requirements
Volume of fluids and blood products transfused during surgery and in the postoperative period.
Measured: During the surgical procedure and the first 48 hours postoperatively.
Coagulation abnormalities (preoperative and postoperative)
Analysis of the coagulation abnormalities (guided by classic coagulation tests and thromboelastometry parameters) resulting from burn debridement surgery
Measured: Preoperative (from admission to surgery) and postoperative (up to 48 hours after surgery).
Duration of Mechanical Ventilation
Number of days on mechanical ventilation after debridement surgery
Measured: 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)
Number of days of ICU stay
Measured: 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
Survival from surgery until 180 days postoperatively.
Measured: From surgery until 180 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start5 Mar 2024
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Syndecan 1Studies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670248
- Sponsor's protocol ID
- PR(AT)400/2023
- Acronym
- GlycoBURN
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Publications
Keyloun JW, Le TD, Brummel-Ziedins KE, Mclawhorn MM, Bravo MC, Orfeo T, Johnson LS, Moffatt LT, Pusateri AE, Shupp JW; SYSCOT Study Group. Inhalation Injury Is Associated With Endotheliopathy and Abnormal Fibrinolytic Phenotypes in Burn Patients: A Cohort Study. J Burn Care Res. 2022 Mar 23;43(2):432-439. doi: 10.1093/jbcr/irab102.
PubMed 34089618Keyloun JW, Le TD, Pusateri AE, Ball RL, Carney BC, Orfeo T, Brummel-Ziedins KE, Bravo MC, McLawhorn MM, Moffatt LT, Shupp JW; and the SYSCOT study group. Circulating Syndecan-1 and Tissue Factor Pathway Inhibitor, Biomarkers of Endothelial Dysfunction, Predict Mortality in Burn Patients. Shock. 2021 Aug 1;56(2):237-244. doi: 10.1097/SHK.0000000000001709.
PubMed 33394974Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards 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. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
PubMed 25058504Luker JN, Vigiola Cruz M, Carney BC, Day A, Moffatt LT, Johnson LS, Shupp JW. Shedding of the endothelial glycocalyx is quantitatively proportional to burn injury severity. Ann Burns Fire Disasters. 2018 Mar 31;31(1):17-22.
PubMed 30174566Osuka A, Kusuki H, Yoneda K, Matsuura H, Matsumoto H, Ogura H, Ueyama M. Glycocalyx Shedding is Enhanced by Age and Correlates with Increased Fluid Requirement in Patients with Major Burns. Shock. 2018 Jul;50(1):60-65. doi: 10.1097/SHK.0000000000001028.
PubMed 29023362Welling H, Henriksen HH, Gonzalez-Rodriguez ER, Stensballe J, Huzar TF, Johansson PI, Wade CE. Endothelial glycocalyx shedding in patients with burns. Burns. 2020 Mar;46(2):386-393. doi: 10.1016/j.burns.2019.05.009. Epub 2019 Dec 20.
PubMed 31866179Rodriguez EG, Ostrowski SR, Cardenas JC, Baer LA, Tomasek JS, Henriksen HH, Stensballe J, Cotton BA, Holcomb JB, Johansson PI, Wade CE. Syndecan-1: A Quantitative Marker for the Endotheliopathy of Trauma. J Am Coll Surg. 2017 Sep;225(3):419-427. doi: 10.1016/j.jamcollsurg.2017.05.012. Epub 2017 Jun 1.
PubMed 28579548Johansson PI, Stensballe J, Ostrowski SR. Shock induced endotheliopathy (SHINE) in acute critical illness - a unifying pathophysiologic mechanism. Crit Care. 2017 Feb 9;21(1):25. doi: 10.1186/s13054-017-1605-5.
PubMed 28179016Tapking C, Hernekamp JF, Horter J, Kneser U, Haug V, Vogelpohl J, Schulte M, Kremer T, Hundeshagen G. Influence of burn severity on endothelial glycocalyx shedding following thermal trauma: A prospective observational study. Burns. 2021 May;47(3):621-627. doi: 10.1016/j.burns.2020.07.021. Epub 2020 Aug 5.
PubMed 32839038Abdullah S, Karim M, Legendre M, Rodriguez L, Friedman J, Cotton-Betteridge A, Drury R, Packer J, Guidry C, Duchesne J, Taghavi S, Jackson-Weaver O. Hemorrhagic Shock and Resuscitation Causes Glycocalyx Shedding and Endothelial Oxidative Stress Preferentially in the Lung and Intestinal Vasculature. Shock. 2021 Nov 1;56(5):803-812. doi: 10.1097/SHK.0000000000001764.
PubMed 34259440Bunch CM, Chang E, Moore EE, Moore HB, Kwaan HC, Miller JB, Al-Fadhl MD, Thomas AV, Zackariya N, Patel SS, Zackariya S, Haidar S, Patel B, McCurdy MT, Thomas SG, Zimmer D, Fulkerson D, Kim PY, Walsh MR, Hake D, Kedar A, Aboukhaled M, Walsh MM. SHock-INduced Endotheliopathy (SHINE): A mechanistic justification for viscoelastography-guided resuscitation of traumatic and non-traumatic shock. Front Physiol. 2023 Feb 27;14:1094845. doi: 10.3389/fphys.2023.1094845. eCollection 2023.
PubMed 36923287Basas VA, Schutzman LM, Brown IE. Implications of the Regulation of Endothelial Glycocalyx Breakdown and Reconstitution in Severe Burn Injury. J Surg Res. 2023 Jun;286:110-117. doi: 10.1016/j.jss.2022.12.033. Epub 2023 Feb 17.
PubMed 36804690Vigiola Cruz M, Carney BC, Luker JN, Monger KW, Vazquez JS, Moffatt LT, Johnson LS, Shupp JW. Plasma Ameliorates Endothelial Dysfunction in Burn Injury. J Surg Res. 2019 Jan;233:459-466. doi: 10.1016/j.jss.2018.08.027. Epub 2018 Sep 22.
PubMed 30502286
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlycoBURN Study: Determination of Endothelial Glycocalyx Status in the Surgical Resuscitation of Severe Burn Patients
- ClinicalTrials.gov ID
- NCT06670248
- Acronym / sponsor ID
- GlycoBURN / PR(AT)400/2023
- Conditions
- Syndecan 1, Severe Burn, Endotheliopathy of Trauma, Endothelial Glycocalyx, Hemorrhagic Shock, Postoperative Complications
- Keywords
- Syndecan 1, Endotheliopathy, Glycocalyx, Proteoglycan, Severe burn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe burn patients | – | Procedure: Debridement Surgery, Diagnostic Test: Sdc-1 Level MeasurementAdult severely burned patients (TBSA ≥ 20%) undergoing debridement surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (10 listed)
- Under 18 years old.
- Pregnant women.
- Patient refusal.
- Polytraumatized patients.
- Electrical or chemical burns.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debridement SurgerySurgical debridement of burn wounds involving ≥ 20% of the TBSA, including debrided and donor sites. | Procedure or surgery | Severe burn patients |
| Sdc-1 Level MeasurementMeasurement 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. | Diagnostic test | Severe burn patients |
Primary outcome
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.
6 secondary outcomes
Postoperative complications
Time frame: 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.
Coagulation abnormalities (preoperative and postoperative)
Time frame: 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.
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).
Survival of severely burned patients after debridement surgery
Time frame: From surgery until 180 days postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Background: PubMed 34089618Keyloun JW, Le TD, Brummel-Ziedins KE, Mclawhorn MM, Bravo MC, Orfeo T, Johnson LS, Moffatt LT, Pusateri AE, Shupp JW; SYSCOT Study Group. Inhalation Injury Is Associated With Endotheliopathy and Abnormal Fibrinolytic Phenotypes in Burn Patients: A Cohort Study. J Burn Care Res. 2022 Mar 23;43(2):432-439. doi: 10.1093/jbcr/irab102.
- Background: PubMed 33394974Keyloun JW, Le TD, Pusateri AE, Ball RL, Carney BC, Orfeo T, Brummel-Ziedins KE, Bravo MC, McLawhorn MM, Moffatt LT, Shupp JW; and the SYSCOT study group. Circulating Syndecan-1 and Tissue Factor Pathway Inhibitor, Biomarkers of Endothelial Dysfunction, Predict Mortality in Burn Patients. Shock. 2021 Aug 1;56(2):237-244. doi: 10.1097/SHK.0000000000001709.
- Background: PubMed 25058504Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards 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. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
- Background: PubMed 30174566Luker JN, Vigiola Cruz M, Carney BC, Day A, Moffatt LT, Johnson LS, Shupp JW. Shedding of the endothelial glycocalyx is quantitatively proportional to burn injury severity. Ann Burns Fire Disasters. 2018 Mar 31;31(1):17-22.
- Background: PubMed 29023362Osuka A, Kusuki H, Yoneda K, Matsuura H, Matsumoto H, Ogura H, Ueyama M. Glycocalyx Shedding is Enhanced by Age and Correlates with Increased Fluid Requirement in Patients with Major Burns. Shock. 2018 Jul;50(1):60-65. doi: 10.1097/SHK.0000000000001028.
- Background: PubMed 31866179Welling H, Henriksen HH, Gonzalez-Rodriguez ER, Stensballe J, Huzar TF, Johansson PI, Wade CE. Endothelial glycocalyx shedding in patients with burns. Burns. 2020 Mar;46(2):386-393. doi: 10.1016/j.burns.2019.05.009. Epub 2019 Dec 20.
- Background: PubMed 28579548Rodriguez EG, Ostrowski SR, Cardenas JC, Baer LA, Tomasek JS, Henriksen HH, Stensballe J, Cotton BA, Holcomb JB, Johansson PI, Wade CE. Syndecan-1: A Quantitative Marker for the Endotheliopathy of Trauma. J Am Coll Surg. 2017 Sep;225(3):419-427. doi: 10.1016/j.jamcollsurg.2017.05.012. Epub 2017 Jun 1.
- Background: PubMed 28179016Johansson PI, Stensballe J, Ostrowski SR. Shock induced endotheliopathy (SHINE) in acute critical illness - a unifying pathophysiologic mechanism. Crit Care. 2017 Feb 9;21(1):25. doi: 10.1186/s13054-017-1605-5.
- Background: PubMed 32839038Tapking C, Hernekamp JF, Horter J, Kneser U, Haug V, Vogelpohl J, Schulte M, Kremer T, Hundeshagen G. Influence of burn severity on endothelial glycocalyx shedding following thermal trauma: A prospective observational study. Burns. 2021 May;47(3):621-627. doi: 10.1016/j.burns.2020.07.021. Epub 2020 Aug 5.
- Background: PubMed 34259440Abdullah S, Karim M, Legendre M, Rodriguez L, Friedman J, Cotton-Betteridge A, Drury R, Packer J, Guidry C, Duchesne J, Taghavi S, Jackson-Weaver O. Hemorrhagic Shock and Resuscitation Causes Glycocalyx Shedding and Endothelial Oxidative Stress Preferentially in the Lung and Intestinal Vasculature. Shock. 2021 Nov 1;56(5):803-812. doi: 10.1097/SHK.0000000000001764.
- Background: PubMed 36923287Bunch CM, Chang E, Moore EE, Moore HB, Kwaan HC, Miller JB, Al-Fadhl MD, Thomas AV, Zackariya N, Patel SS, Zackariya S, Haidar S, Patel B, McCurdy MT, Thomas SG, Zimmer D, Fulkerson D, Kim PY, Walsh MR, Hake D, Kedar A, Aboukhaled M, Walsh MM. SHock-INduced Endotheliopathy (SHINE): A mechanistic justification for viscoelastography-guided resuscitation of traumatic and non-traumatic shock. Front Physiol. 2023 Feb 27;14:1094845. doi: 10.3389/fphys.2023.1094845. eCollection 2023.
- Background: PubMed 36804690Basas VA, Schutzman LM, Brown IE. Implications of the Regulation of Endothelial Glycocalyx Breakdown and Reconstitution in Severe Burn Injury. J Surg Res. 2023 Jun;286:110-117. doi: 10.1016/j.jss.2022.12.033. Epub 2023 Feb 17.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syndecan 1 and Severe Burn, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Pons Pellicé, MD (+34 626498575, laura.pons@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sdc-1 perioperative changes (time frame: From admission to our Burn Unit until 48 hours post-debridement surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06670248, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.