Damage and Renal Clearance of Glycocalyx in Cardiac Surgery (GlycoCarSur)

April 7, 2020 updated by: Miguel Ayala León

The glycocalyx is a component of the vascular endothelium that currently plays a relevant role in the modified Starling theory.

The manipulation of the heart during cardiac surgery stimulates the release of the natriuretic atrial peptide, which causes endothelial wear in patients undergoing extracorporeal circulation. Dilation of the atrium produces natriuretic atrial peptide, which reduces plasma volume by increasing renal excretion and vascular permeability. The atrial peptide degrades the surface of the coronary endothelium, causing loss of the side cam protein nucleus. This study investigates the relationship between clamping time in cardiac surgery and the clearance of endothelial inflammation markers.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Puebla, Mexico, 72090
        • Hospital Beneficencia Española de Puebla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 who meet the selection criteria undergoing cardiac surgery for a single valve change or replacement.

Description

Inclusion Criteria:

  • Over 18 years of age
  • Patients who underwent cardiac surgery for a single valve change or replacement

Exclusion Criteria:

  • Stage 3 renal failure patients
  • Patients with a previous diagnosis of hematological malignancy
  • Patients undergoing pulmonary valve change surgery.
  • Patients undergoing Bentall and Bono surgery.
  • Patients Undergoing Coronary Artery Bypass Surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Extracorporeal circulation time
Time Frame: 2 hours
Duration of Extracorporeal Circulation in minutes
2 hours
Aortic clamping time
Time Frame: 2 hours
Duration of aortic clamping time in minutes
2 hours
Hyaluronic acid levels in blood before surgery
Time Frame: 30 minutes
Quantity of hyaluronic acid in blood before surgery
30 minutes
Hyaluronic acid levels in blood after surgery
Time Frame: 30 minutes
Quantity of hyaluronic acid in blood after surgery
30 minutes
Hyaluronic acid levels in urine before surgery
Time Frame: 30 minutes
Quantity of hyaluronic acid in urine before surgery
30 minutes
Hyaluronic acid levels in urine after surgery
Time Frame: 30 minutes
Quantity of hyaluronic acid in urine before surgery
30 minutes
Sydecan -1 levels in blood before surgery
Time Frame: 30 minutes
Quantity of Sydecan -1 in blood before surgery
30 minutes
Sydecan -1 levels in blood after surgery
Time Frame: 30 minutes
Quantity of Sydecan -1 in blood after surgery
30 minutes
Sydecan -1 levels in urine before surgery
Time Frame: 30 minutes
Quantity of Sydecan -1 in urine before surgery
30 minutes
Sydecan -1 levels in urine after surgery
Time Frame: 30 minutes
Quantity of Sydecan -1 in urine after surgery
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miguel Ayala León

Collaborators

Instituto Nacional de Cardiologia Ignacio Chavez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cardiologia-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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