Impact of Perioperative Shedding of the Endothelial Glycocalyx on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery.

NCT ID: NCT03197051

Last Updated: 2019-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-25

Study Completion Date

2018-07-11

Brief Summary

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Endothelial glycocalyx, the luminal structure of healthy vasculature, plays critical roles in regulation of inflammatory responses, vascular permeability, blood coagulation. It can be easily damaged by ischemia/reperfusion, hypoxemia, oxidative stress, endotoxin. Accordingly, the relationship between the shedding of endothelial glycocalyx and the prognosis of diseases such as diabetes mellitus, atherosclerosis, malignancy has been researched.

In cases of cardiac surgery, patients cannot help but be exposed to ischemia/reperfusion, oxidative stress which can damage endothelial glycocalyx. In this research, the investigators would like to discover the impact of perioperative shedding of the endothelial glycocalyx on the incidence of postoperative acute kidney injury in patients undergoing valvular heart surgery.

Detailed Description

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Syndecan-1, Heparan sulfate serve as biomarkers of glycocalyx degradation. Both biomarkers will be measured 2 times, before the anesthetic induction, and immediately after weaning from cardiopulmonary bypass, during the valvular heart surgery.

Postoperative acute kidney injury up to postoperative 48 hours, Composite morbidity and mortality up to postoperative 30 days will be checked.

Conditions

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Valvular Heart Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Q1

Measure the Concentration of Syndecan-1, Heparan sulfate before anesthetic induction and immediately after weaning from cardiopulmonary bypass. Categorize the patients by serum syndecan-1 concentration(off-CPB) quartile. Q1 means a group of lowest 25% of serum syndecan-1 concentration.

No interventions assigned to this group

Q2

Q2 means a group of lower 25\~50% of serum syndecan-1 concentration.

No interventions assigned to this group

Q3

Q3 means a group of higher 50\~75% of serum syndecan-1 concentration.

No interventions assigned to this group

Q4

Q4 means a group of highest 75\~100% of serum syndecan-1 concentration.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\- Patients undergoing valvular heart surgery (\>20 years old)

Exclusion Criteria

* Emergency operation
* Aorta surgery (Graft replacement of Total arch or Descending thoracic aorta)
* Minimal invasive surgery
* Chronic kidney disease (eGFR\<30mL/min/1.73m2) / Dialysis history
* Infective endocarditis
* Malignancy
* Patients who cannot give Informed consent (e.g. Illiterate, Foreigners)
* Patients who are already enrolled to another study than can affect the results
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2017-0340

Identifier Type: -

Identifier Source: org_study_id

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