Evaluation of Glycocalyx in Major Abdominal and Thoracic Surgery

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04900779

Collaborator

(none)

117

Enrollment

Location

15.9

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

The glycocalyx is a fundamental component of the endothelial barrier and alterations at this level have been shown to exacerbate the inflammatory response in the microcirculation. Its degradation in the surgical patient, has been tested in interventions that involve regional or general ischemia, for example in cardiac surgery, major vascular surgery or transplantation. On interventions that do not involve ischemic events the literature is limited, such is the case of those patients undergoing major abdominal and thoracic surgery.

Objective:

Assess whether there is a glycocalyx degradation in major elective abdominal and thoracic surgery, measured as an increase in plasma syndecane-1 levels during the first 24 hours of postoperative care.

Methodology:

Prospective observational study in patients undergoing major elective thoracic and abdominal surgery at the University Hospital Vall d´Hebrón. Measurement of the syndecane-1 plasma levels are going to be done during the first 24 hours after the intervention. It is intended to evaluate whether its elevation is related to anesthetic perioperative factors, and if it has an impact con morbildity and mortality in the following 6 months after the procedure.

Condition or Disease	Intervention/Treatment	Phase
Major Elective Abdominal and Thoracic Surgery

Study Design

Study Type:

Observational

Anticipated Enrollment :

117 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Observational Study to Evaluate Glycocalyx Alteration in Major Abdominal and Thoracic Surgery

Actual Study Start Date :

Feb 2, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

May 31, 2022

Outcome Measures

Primary Outcome Measures

plasmatic syndecan -1 levels [In the first 24 hours after the procedure]
Degradation of glucocalix measured by plasmatic syndecan -1 levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients older than 18 years old
Patients that are scheduled to major abdominal and thoracic elective surgery in Universtity Hospital Vall d´ Hebrón.
Patients ASA I, II and III.
Patients that after the intervention have their recovering in the Surgical ICU

Exclusion Criteria:

Patients ASA IV and V.
Patients that are hospitilized previous to the surgery.
Patients that undergo emergent surgery.
Patients with Chronic or Acute Renal Failure previous to the surgery.
Patients with past medical history of autoinmune disseases.
Patients with an active infection previous to the surgery.
Patients in treatment with steroids previous to the surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitari Vall d´Hebron	Barcelona		Spain

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital Universitari Vall d'Hebron Research Institute

ClinicalTrials.gov Identifier:

NCT04900779

Other Study ID Numbers:

PR(AG)569/2020

First Posted:

May 25, 2021

Last Update Posted:

May 25, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Aneurysm, Dissecting

Study Results

No Results Posted as of May 25, 2021