GlycocalyxGlycoCarSurNCT04332952
Damage and Renal Clearance of Glycocalyx in Cardiac Surgery
An observational study of Glycocalyx and Cardio-Renal Syndrome, run by Miguel Ayala León at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glycocalyx, Cardio-Renal Syndrome
- How many people
- 21 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2017to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet the selection criteria undergoing cardiac surgery for a single valve change or replacement.
Who may be able to join
- Over 18 years of age
- Patients who underwent cardiac surgery for a single valve change or replacement
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Glycocalyx, Cardio-Renal Syndrome
- Keywords
- Renal clearance, Glycocalyx, Cardiac surgery
- Medical subject headings
- Cardio-Renal Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracorporeal circulation time
Duration of Extracorporeal Circulation in minutes
Measured: 2 hours
Aortic clamping time
Duration of aortic clamping time in minutes
Measured: 2 hours
Hyaluronic acid levels in blood before surgery
Quantity of hyaluronic acid in blood before surgery
Measured: 30 minutes
Hyaluronic acid levels in blood after surgery
Quantity of hyaluronic acid in blood after surgery
Measured: 30 minutes
Hyaluronic acid levels in urine before surgery
Quantity of hyaluronic acid in urine before surgery
Measured: 30 minutes
Hyaluronic acid levels in urine after surgery
Quantity of hyaluronic acid in urine before surgery
Measured: 30 minutes
Sydecan -1 levels in blood before surgery
Quantity of Sydecan -1 in blood before surgery
Measured: 30 minutes
Sydecan -1 levels in blood after surgery
Quantity of Sydecan -1 in blood after surgery
Measured: 30 minutes
Sydecan -1 levels in urine before surgery
Quantity of Sydecan -1 in urine before surgery
Measured: 30 minutes
Sydecan -1 levels in urine after surgery
Quantity of Sydecan -1 in urine after surgery
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Aug 2017
- Primary completion1 Oct 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlycocalyxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miguel Ayala León
- Sponsor type
- Research network
- Collaborators
- Instituto Nacional de Cardiologia Ignacio Chavez
- Responsible party
- Sponsor-investigator, Miguel Ayala León, Hospital Beneficencia Espanola de Puebla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332952
- Sponsor's protocol ID
- Cardiologia-002
- Acronym
- GlycoCarSur
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Damage and Renal Clearance of Glycocalyx in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04332952
- Acronym / sponsor ID
- GlycoCarSur / Cardiologia-002
- Conditions
- Glycocalyx, Cardio-Renal Syndrome
- Keywords
- Renal clearance, Glycocalyx, Cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Miguel Ayala LeónResearch network
- Collaborators
- Instituto Nacional de Cardiologia Ignacio Chavez
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the selection criteria undergoing cardiac surgery for a single valve change or replacement.
Key inclusion criteria (2 listed)
- Over 18 years of age
- Patients who underwent cardiac surgery for a single valve change or replacement
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extracorporeal circulation time
Time frame: 2 hours
Duration of Extracorporeal Circulation in minutes
Aortic clamping time
Time frame: 2 hours
Duration of aortic clamping time in minutes
Hyaluronic acid levels in blood before surgery
Time frame: 30 minutes
Quantity of hyaluronic acid in blood before surgery
Hyaluronic acid levels in blood after surgery
Time frame: 30 minutes
Quantity of hyaluronic acid in blood after surgery
Hyaluronic acid levels in urine before surgery
Time frame: 30 minutes
Quantity of hyaluronic acid in urine before surgery
Hyaluronic acid levels in urine after surgery
Time frame: 30 minutes
Quantity of hyaluronic acid in urine before surgery
Sydecan -1 levels in blood before surgery
Time frame: 30 minutes
Quantity of Sydecan -1 in blood before surgery
Sydecan -1 levels in blood after surgery
Time frame: 30 minutes
Quantity of Sydecan -1 in blood after surgery
Sydecan -1 levels in urine before surgery
Time frame: 30 minutes
Quantity of Sydecan -1 in urine before surgery
Sydecan -1 levels in urine after surgery
Time frame: 30 minutes
Quantity of Sydecan -1 in urine after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Individual participant dataSharing planned: No
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glycocalyx and Cardio-Renal Syndrome, run by Miguel Ayala León at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracorporeal circulation time (time frame: 2 hours). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.