Evaluation of Glycocalyx in Major Abdominal and Thoracic Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Major Elective Abdominal and Thoracic Surgery

• Study Type: Observational
• Enrollment (Anticipated): 117

Contacts and Locations

• Study Contact: Name: Lysha M Laurens; Phone Number: +34698209872; Email: michelle.laurens.a@gmail.com

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Universitari Vall d´Hebrón
    • Contact: Lysha M Laurens; Phone Number: +34698209872

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 years old that undergo major abdominal and thoracic elective surgery in University Hospital Vall d´Hebron.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasmatic syndecan -1 levels	Degradation of glucocalix measured by plasmatic syndecan -1 levels	In the first 24 hours after the procedure

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: PR(AG)569/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No