Valvular Heart DiseaseNCT03197051
Impact of Perioperative Shedding of the Endothelial Glycocalyx on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery.
An observational study of Valvular Heart Disease, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Valvular Heart Disease
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jun 2017to 11 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing valvular heart surgery (>20 years old)
Who may be able to join
- Patients undergoing valvular heart surgery (>20 years old)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 03722
About this study
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.
Read the 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.
- Conditions
- Valvular Heart Disease
- Keywords
- Endothelial glycocalyx, Acute kidney injury, Valvular heart disease
- Medical subject headings
- Heart Valve Diseases, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to Postoperative 48 hours
Secondary outcomes (1)
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
Measured: Up to postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start25 Jun 2017
- Primary completion11 Jul 2018
- Study completion11 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197051
- Sponsor's protocol ID
- 4-2017-0340
- Status last verified
- Jan 2019
- First submitted
- 20 Jun 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perioperative Shedding of the Endothelial Glycocalyx on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery.
- ClinicalTrials.gov ID
- NCT03197051
- Acronym / sponsor ID
- 4-2017-0340
- Conditions
- Valvular Heart Disease
- Keywords
- Endothelial glycocalyx, Acute kidney injury, Valvular heart disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 25 Jun 2017 (actual)
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing valvular heart surgery (>20 years old)
Key inclusion criteria (1 listed)
- Patients undergoing valvular heart surgery (>20 years old)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Composite morbidity and mortality (by STS Major morbidity endpoint)
Time frame: Up to postoperative 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (time frame: Up to Postoperative 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.