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

Valvular Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197051
• Other study ID #: 4-2017-0340
• Status: Completed
• Start date: June 25, 2017
• Est. completion date: July 11, 2018

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 11, 2018
• Est. primary completion date: July 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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