Evaluation of Glycocalyx in Major Abdominal and Thoracic Surgery

• Conditions: Major Elective Abdominal and Thoracic Surgery

• Registration Number: NCT04900779
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-02
• Status Verified: 2021-05
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-24
• Last Update Submitted: 2021-05-24
• Study First Posted: 2021-05-25
• Last Update Posted: 2021-05-25
• Primary Completion: 2021-12-01
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 117

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
plasmatic syndecan -1 levels	In the first 24 hours after the procedure	Degradation of glucocalix measured by plasmatic syndecan -1 levels

Trial Locations

Locations (1)

Hospital Universitari Vall d´Hebron; 🇪🇸 Barcelona, Spain