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

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.

Study Overview

• Status: Completed
• Conditions: Valvular Heart Disease

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing valvular heart surgery (>20 years old)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.
Q2; Q2 means a group of lower 25~50% of serum syndecan-1 concentration.
Q3; Q3 means a group of higher 50~75% of serum syndecan-1 concentration.
Q4; Q4 means a group of highest 75~100% of serum syndecan-1 concentration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute kidney injury	Acute kidney injury is classified under KDIGO guideline. Stage I; Serum creatinine (Scr) : 1.5 to 1.9 times baseline or ≥26μmol/L (≥3.0mg/dL) increase; Urine output : <0.5mL/kg/kr for 6~12hrs Stage II; Serum creatinine (Scr) : 2.0 to 2.9 times baseline; Urine output : <0.5mL/kg/hr for ≥12hrs Stage III; Serum creatinine (Scr) : 3.0 times baseline or ≥354μmol/L (≥4.0mg/dL) increase or Initiation for RRT; Urine output : <0.3mL/kg/hr for ≥24hrs or Anuria for ≥12hrs	Up to Postoperative 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite morbidity and mortality (by STS Major morbidity endpoint)	STS Major morbidity endpoint; Mortality for postoperative 30 days irrelevant to causes; Permanent stroke; Wound infection; Prolonged ventilation greater than 48 hours; Cardiac surgery reoperation	Up to postoperative 30 days

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2017
• Primary Completion (Actual): July 11, 2018
• Study Completion (Actual): July 11, 2018

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Acute kidney injury; Valvular heart disease; Endothelial glycocalyx
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Heart Diseases; Acute Kidney Injury; Heart Valve Diseases
• Other Study ID Numbers: 4-2017-0340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No