## Protocol Section
### Identification Module
**NCT ID:** NCT04900779

**Brief Title:** Evaluation of Glycocalyx in Major Abdominal and Thoracic Surgery

**Official Title:** Prospective Observational Study to Evaluate Glycocalyx Alteration in Major Abdominal and Thoracic Surgery

#### Organization Study ID Info
**ID:** PR(AG)569/2020
#### Organization
**Class:** OTHER
**Full Name:** Hospital Universitari Vall d'Hebron Research Institute
### Status Module
#### Completion Date
**Date:** 2022-05-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-05-25

**Type:** ACTUAL

**Last Update Submit Date:** 2021-05-24

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-02-02

**Type:** ACTUAL

**Status Verified Date:** 2021-05

#### Study First Post Date
**Date:** 2021-05-25
**Type:** ACTUAL
**Study First Submit Date:** 2021-05-20
**Study First Submit QC Date:** 2021-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospital Universitari Vall d'Hebron Research Institute

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Major Elective Abdominal and Thoracic Surgery

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 117

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Degradation of glucocalix measured by plasmatic syndecan -1 levels

**Measure:** plasmatic syndecan -1 levels

**Time Frame:** In the first 24 hours after the procedure

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** michelle.laurens.a@gmail.com

**Name:** Lysha M Laurens

**Phone:** +34698209872

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Barcelona

**Contacts:**

***Contact 1:***

- **Name:** Lysha M Laurens

- **Phone:** +34698209872

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitari Vall d´Hebron

**Status:** RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000094665

- Term: Dissection, Blood Vessel

- ID: D000000783

- Term: Aneurysm

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000094683

- Term: Acute Aortic Syndrome

- ID: D000001018

- Term: Aortic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4114

- Name: Aortic Dissection

- Relevance: HIGH

- As Found: Thoracic

- ID: M3081

- Name: Dissection, Blood Vessel

- Relevance: LOW

- As Found: Unknown

- ID: M4113

- Name: Aneurysm

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M3085

- Name: Acute Aortic Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M4334

- Name: Aortic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000784

- Term: Aortic Dissection

### Misc Info Module

- Version Holder: 2024-05-24
