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.

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Key information

Conditions

Valvular Heart Disease Acute Kidney Injury Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Valve Diseases Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Seoul, 03722, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Acute kidney injury

Time frame: 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 outcomes

Composite morbidity and mortality (by STS Major morbidity endpoint)

Time frame: 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Jun 23, 2017
Registry last updated: Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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