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CompletedNCT04332952GlycoCarSurUpdated Apr 9, 2020

Damage and Renal Clearance of Glycocalyx in Cardiac Surgery

An observational study in Glycocalyx and Cardio-Renal Syndrome, sponsored by Miguel Ayala León. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-09.

Sponsored by Miguel Ayala León · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
21
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Glycocalyx
  • Cardio-Renal Syndrome

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Keywords

  • Renal clearance
  • Glycocalyx
  • Cardiac surgery
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In context

Cardio-Renal Syndrome

76 studies on the registry are indexed under Cardio-Renal Syndrome; 22 are open to participants now.

This study's enrollment of 21 is below the median of 150 across 26 observational studies indexed under Cardio-Renal Syndrome.

Browse Cardio-Renal Syndrome studies →

Lead sponsor

Miguel Ayala León is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
21 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Extracorporeal circulation time

    Duration of Extracorporeal Circulation in minutes

    Time frame: 2 hours

  2. Aortic clamping time

    Duration of aortic clamping time in minutes

    Time frame: 2 hours

  3. Hyaluronic acid levels in blood before surgery

    Quantity of hyaluronic acid in blood before surgery

    Time frame: 30 minutes

  4. Hyaluronic acid levels in blood after surgery

    Quantity of hyaluronic acid in blood after surgery

    Time frame: 30 minutes

  5. Hyaluronic acid levels in urine before surgery

    Quantity of hyaluronic acid in urine before surgery

    Time frame: 30 minutes

  6. Hyaluronic acid levels in urine after surgery

    Quantity of hyaluronic acid in urine before surgery

    Time frame: 30 minutes

  7. Sydecan -1 levels in blood before surgery

    Quantity of Sydecan -1 in blood before surgery

    Time frame: 30 minutes

  8. Sydecan -1 levels in blood after surgery

    Quantity of Sydecan -1 in blood after surgery

    Time frame: 30 minutes

  9. Sydecan -1 levels in urine before surgery

    Quantity of Sydecan -1 in urine before surgery

    Time frame: 30 minutes

  10. Sydecan -1 levels in urine after surgery

    Quantity of Sydecan -1 in urine after surgery

    Time frame: 30 minutes

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Study locations

1 site
  • Hospital Beneficencia Española de Puebla
    Puebla, 72090, Mexico
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04332952
Lead sponsor
Miguel Ayala León
Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
Responsible party
Miguel Ayala León (cardiovascular critical care unit director, Hospital Beneficencia Espanola de Puebla) — Sponsor-investigator
First posted
Apr 3, 2020
Start date
Aug 1, 2017
Primary completion
Oct 1, 2017
Completion
Dec 31, 2017
Last update
Apr 9, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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