Brief Summary

The glycocalyx is a layer of macromolecules that covers the luminal surface of the endothelium, playing an important role in vascular homeostasis. Several studies have shown that in conditions of sepsis there is a degradation of the glycocalyx mediated by inflammatory mechanisms, releasing its components into the bloodstream. These glycocalyx fragments can be measured in blood plasma, showing a correlation between these markers and organ dysfunction, severity and mortality in sepsis situations. However, despite the great interest in glycocalyx biomarkers, their values in patients undergoing colorectal surgery are not well known. Therefore, verifying whether plasma levels of glycocalyx damage markers increase in the perioperative period of colorectal surgery is of great interest at the pathophysiological and clinical level, since the correlation of these markers with postoperative clinical evolution is unknown. In this study we want to determine the plasma levels of Heparan-sulphate and Syndecan-1, two of the most important constituents of the glycocalyx, and perform several measurements to form a "time course" of the plasma levels of these markers, in order to compare the different subgroups of patients undergoing colorectal surgery based on their clinical and surgical characteristics.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 months study duration

First Submitted

Initial submission to the registry

May 30, 2022

Completed

2 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed

14 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed

Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

May 30, 2022

Last Update Submit

July 27, 2022

Conditions

Endothelial Dysfunction

Keywords

GlycocalixHeparan-sulphateSyndecan-1Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

To analyze plasma levels changes of heparan-sulphate and syndecan-1 in perioperative period of colorectal surgery
To analyze plasma levels changes of glycocalyx damage markers (Heparan-sulphate and Syndecan-1) at 5 times: preoperatively, 2 hours after surgery, 6 hours after surgery, 24 hours after surgery, and 48 hours after surgery, to perform a "time cours" of the plasma levels of this markers. This determinations will be made by ELISA technique.
Blood samples will be collected in 5 times: preoperatively, at 2 hours after surgery, 6 hours after surgery, 24 hours after surgery and 48 hours after surgery.

Secondary Outcomes (3)

C-reactive Protein, procalcitonin, lactate, complete blood count, coagulation and basic biochemistry
Blood samples will be collected in 5 times: preoperatively, at 2 hours after surgery, 6 hours after surgery, 24 hours after surgery and 48 hours after surgery.
To analyze the possible relationship of glycocalyx damage markers with different parameters depending on the patient and the surgical intervention
Blood samples will be collected in 5 times: preoperatively, at 2 hours after surgery, 6 hours after surgery, 24 hours after surgery and 48 hours after surgery.
To study other clinical parameters that may indicate a possible postoperative complication and its relationship with markers of endothelial glycocalyx damage.
Blood samples will be collected in 5 times: preoperatively, at 2 hours after surgery, 6 hours after surgery, 24 hours after surgery and 48 hours after surgery.

Study Arms (1)

colorectal surgery patients

In patients undergoing colorectal surgery, blood samples will be collected at 5 times: preoperatively, and at 2, 6, 24 and 48 hours after finishing surgery, respectively.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The study population (value of n) has been calculated on a population of 100 patients who will undergo surgery approximately one year. With a confidence level of 95% and a margin of error of 5%, a sample size of 80 patients has been calculated. These 80 patients will be older than 18 years old, men and women, undergoing elective or emergency colorectal surgery (right hemicolectomy, extended right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection of the rectum or abdominoperineal amputation)

You may qualify if:

Signing of the informed consent document.
Age equal to or greater than 18 years.
American Society of Anesthesiologists (ASA) surgical risk ≤ III.
Undergoing colorectal surgery

You may not qualify if:

Age \< 18 years old
Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valencianalead

Study Sites (1)

Nuria Garcia Del Olmo

Valencia, 46003, Spain

RECRUITING

Related Publications (19)

Reitsma S, Slaaf DW, Vink H, van Zandvoort MA, oude Egbrink MG. The endothelial glycocalyx: composition, functions, and visualization. Pflugers Arch. 2007 Jun;454(3):345-59. doi: 10.1007/s00424-007-0212-8. Epub 2007 Jan 26.
PMID: 17256154RESULT
Weinbaum S, Tarbell JM, Damiano ER. The structure and function of the endothelial glycocalyx layer. Annu Rev Biomed Eng. 2007;9:121-67. doi: 10.1146/annurev.bioeng.9.060906.151959.
PMID: 17373886RESULT
Vink H, Duling BR. Capillary endothelial surface layer selectively reduces plasma solute distribution volume. Am J Physiol Heart Circ Physiol. 2000 Jan;278(1):H285-9. doi: 10.1152/ajpheart.2000.278.1.H285.
PMID: 10644610RESULT
van den Berg BM, Vink H, Spaan JA. The endothelial glycocalyx protects against myocardial edema. Circ Res. 2003 Apr 4;92(6):592-4. doi: 10.1161/01.RES.0000065917.53950.75. Epub 2003 Mar 13.
PMID: 12637366RESULT
van Haaren PM, VanBavel E, Vink H, Spaan JA. Charge modification of the endothelial surface layer modulates the permeability barrier of isolated rat mesenteric small arteries. Am J Physiol Heart Circ Physiol. 2005 Dec;289(6):H2503-7. doi: 10.1152/ajpheart.00587.2005. Epub 2005 Aug 12.
PMID: 16100247RESULT
Mochizuki S, Vink H, Hiramatsu O, Kajita T, Shigeto F, Spaan JA, Kajiya F. Role of hyaluronic acid glycosaminoglycans in shear-induced endothelium-derived nitric oxide release. Am J Physiol Heart Circ Physiol. 2003 Aug;285(2):H722-6. doi: 10.1152/ajpheart.00691.2002. Epub 2003 May 1.
PMID: 12730059RESULT
Constantinescu AA, Vink H, Spaan JA. Endothelial cell glycocalyx modulates immobilization of leukocytes at the endothelial surface. Arterioscler Thromb Vasc Biol. 2003 Sep 1;23(9):1541-7. doi: 10.1161/01.ATV.0000085630.24353.3D. Epub 2003 Jul 10.
PMID: 12855481RESULT
Mulivor AW, Lipowsky HH. Inflammation- and ischemia-induced shedding of venular glycocalyx. Am J Physiol Heart Circ Physiol. 2004 May;286(5):H1672-80. doi: 10.1152/ajpheart.00832.2003. Epub 2004 Jan 2.
PMID: 14704229RESULT
Lipowsky HH. The endothelial glycocalyx as a barrier to leukocyte adhesion and its mediation by extracellular proteases. Ann Biomed Eng. 2012 Apr;40(4):840-8. doi: 10.1007/s10439-011-0427-x. Epub 2011 Oct 8.
PMID: 21984514RESULT
Thi MM, Tarbell JM, Weinbaum S, Spray DC. The role of the glycocalyx in reorganization of the actin cytoskeleton under fluid shear stress: a "bumper-car" model. Proc Natl Acad Sci U S A. 2004 Nov 23;101(47):16483-8. doi: 10.1073/pnas.0407474101. Epub 2004 Nov 15.
PMID: 15545600RESULT
Henry CB, Duling BR. TNF-alpha increases entry of macromolecules into luminal endothelial cell glycocalyx. Am J Physiol Heart Circ Physiol. 2000 Dec;279(6):H2815-23. doi: 10.1152/ajpheart.2000.279.6.H2815.
PMID: 11087236RESULT
Vink H, Constantinescu AA, Spaan JA. Oxidized lipoproteins degrade the endothelial surface layer : implications for platelet-endothelial cell adhesion. Circulation. 2000 Apr 4;101(13):1500-2. doi: 10.1161/01.cir.101.13.1500.
PMID: 10747340RESULT
Adamson RH. Permeability of frog mesenteric capillaries after partial pronase digestion of the endothelial glycocalyx. J Physiol. 1990 Sep;428:1-13. doi: 10.1113/jphysiol.1990.sp018197.
PMID: 2231409RESULT
Huxley VH, Williams DA. Role of a glycocalyx on coronary arteriole permeability to proteins: evidence from enzyme treatments. Am J Physiol Heart Circ Physiol. 2000 Apr;278(4):H1177-85. doi: 10.1152/ajpheart.2000.278.4.H1177.
PMID: 10749712RESULT
VanTeeffelen JW, Dekker S, Fokkema DS, Siebes M, Vink H, Spaan JA. Hyaluronidase treatment of coronary glycocalyx increases reactive hyperemia but not adenosine hyperemia in dog hearts. Am J Physiol Heart Circ Physiol. 2005 Dec;289(6):H2508-13. doi: 10.1152/ajpheart.00446.2005. Epub 2005 Jul 22.
PMID: 16040715RESULT
Becker BF, Chappell D, Bruegger D, Annecke T, Jacob M. Therapeutic strategies targeting the endothelial glycocalyx: acute deficits, but great potential. Cardiovasc Res. 2010 Jul 15;87(2):300-10. doi: 10.1093/cvr/cvq137. Epub 2010 May 11.
PMID: 20462866RESULT
Uchimido R, Schmidt EP, Shapiro NI. The glycocalyx: a novel diagnostic and therapeutic target in sepsis. Crit Care. 2019 Jan 17;23(1):16. doi: 10.1186/s13054-018-2292-6.
PMID: 30654825RESULT
Yanase F, Naorungroj T, Bellomo R. Glycocalyx damage biomarkers in healthy controls, abdominal surgery, and sepsis: a scoping review. Biomarkers. 2020 Sep;25(6):425-435. doi: 10.1080/1354750X.2020.1787518. Epub 2020 Jul 4.
PMID: 32597227RESULT
Steppan J, Hofer S, Funke B, Brenner T, Henrich M, Martin E, Weitz J, Hofmann U, Weigand MA. Sepsis and major abdominal surgery lead to flaking of the endothelial glycocalix. J Surg Res. 2011 Jan;165(1):136-41. doi: 10.1016/j.jss.2009.04.034. Epub 2009 May 20.
PMID: 19560161RESULT

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

Study Officials

Nuria García del Olmo
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuria García del Olmo

CONTACT

+0034 619 660 434 nuriagarciadelolmo@gmail.com

Jose Gracía de la Asunción

CONTACT

+0034 606 265 437 josegarciadelaasunción@gmail.com

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 2 Days
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Medical Doctor Specialist in General Surgery and Digestive System

Study Record Dates

First Submitted

May 30, 2022

First Posted

June 15, 2022

Study Start

June 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

August 1, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing: Will not share

Locations

ES(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

colorectal surgery patients

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (19)

Biospecimen

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations