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

Completed

• Conditions: Valvular Heart Disease

• Registration Number: NCT03197051
• Lead Sponsor: Yonsei University

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-23
• Study Start: 2017-06-25
• Primary Completion: 2018-07-11
• Study Completion: 2018-07-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Patients undergoing valvular heart surgery (>20 years old)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute kidney injury	Up to Postoperative 48 hours	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

Secondary Outcome Measures

Name	Time	Method
Composite morbidity and mortality (by STS Major morbidity endpoint)	Up to postoperative 30 days	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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of