NCT04332952

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

April 1, 2020

Last Update Submit

April 7, 2020

Conditions

Keywords

Renal clearanceGlycocalyxCardiac surgery

Outcome Measures

Primary Outcomes (10)

  • Extracorporeal circulation time

    Duration of Extracorporeal Circulation in minutes

    2 hours

  • Aortic clamping time

    Duration of aortic clamping time in minutes

    2 hours

  • Hyaluronic acid levels in blood before surgery

    Quantity of hyaluronic acid in blood before surgery

    30 minutes

  • Hyaluronic acid levels in blood after surgery

    Quantity of hyaluronic acid in blood after surgery

    30 minutes

  • Hyaluronic acid levels in urine before surgery

    Quantity of hyaluronic acid in urine before surgery

    30 minutes

  • Hyaluronic acid levels in urine after surgery

    Quantity of hyaluronic acid in urine before surgery

    30 minutes

  • Sydecan -1 levels in blood before surgery

    Quantity of Sydecan -1 in blood before surgery

    30 minutes

  • Sydecan -1 levels in blood after surgery

    Quantity of Sydecan -1 in blood after surgery

    30 minutes

  • Sydecan -1 levels in urine before surgery

    Quantity of Sydecan -1 in urine before surgery

    30 minutes

  • Sydecan -1 levels in urine after surgery

    Quantity of Sydecan -1 in urine after surgery

    30 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Beneficencia Española de Puebla

Puebla City, 72090, Mexico

Location

MeSH Terms

Conditions

Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHeart FailureHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR INVESTIGATOR
PI Title
cardiovascular critical care unit director

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 3, 2020

Study Start

August 1, 2017

Primary Completion

October 1, 2017

Study Completion

December 31, 2017

Last Updated

April 9, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations