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

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Yonsei University

Status

Completed

Conditions

Valvular Heart Disease

Study type

Observational

Funder types

Other

Identifiers

NCT03197051
4-2017-0340

Details and patient eligibility

About

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.

Full description

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.

Enrollment

250 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

250 participants in 4 patient groups

Q1
Description:
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.
Q2
Description:
Q2 means a group of lower 25\~50% of serum syndecan-1 concentration.
Q3
Description:
Q3 means a group of higher 50\~75% of serum syndecan-1 concentration.
Q4
Description:
Q4 means a group of highest 75\~100% of serum syndecan-1 concentration.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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