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Clinical Trials/NCT04900779
NCT04900779
Unknown
Not Applicable

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

Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country117 target enrollmentFebruary 2, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Elective Abdominal and Thoracic Surgery
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
117
Locations
1
Primary Endpoint
plasmatic syndecan -1 levels
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2, 2021
End Date
May 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

plasmatic syndecan -1 levels

Time Frame: In the first 24 hours after the procedure

Degradation of glucocalix measured by plasmatic syndecan -1 levels

Study Sites (1)

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