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

NCT03197051 | Completed

• 1 other identifier: 4-2017-0340
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Valvular Heart Disease

Keywords

Endothelial glycocalyx; Acute kidney injury; Valvular heart disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Composite morbidity and mortality (by STS Major morbidity endpoint)

  Up to postoperative 30 days

Study Arms (4)

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Heart Valve Diseases; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 23, 2017
• Study Start: June 25, 2017
• Primary Completion: July 11, 2018
• Study Completion: July 11, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)