Cardiac AnaesthesiaNCT06581289
Cardiac Anesthesia Registry Including Biosignal Database for Prognostication of Postoperative Renal Outcome
An observational study of Cardiac Anaesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
AKI(Acute Kidney Injury) is a common complication after cardiac surgery which is associated with increased mortality and morbidity. Collecting perioperative biosignal data and studying their association with renal outcomes can help improve kidney injury, mortality, and morbidity in cardiac surgical patients. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Cardiac Anaesthesia
- How many people
- 10,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2024to 30 Sep 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients aged 19 year and older admitted to Severance cardiovascular hospital for cardiac surgery using CPB (Cardiopulmonary bypass).
Who may be able to join
- Aged 19 years and older scheduled for cardiac surgery using CPB
Who cannot join
- emergency operation, the patient is foreigner or illiterate and unable to read the consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Severance Hospital
Seoul
SUNGMIN SUH, MD, 82-10-8916-5701, suh5701@yuhs.ac
About this study
Official title: Cardiac Anesthesia Registry Including Biosignal Database for Prognostication of Postoperative Renal Outcome: Cardiac Anesthesia Renal Outcome in Severance Cardiovascular Hospital - DataBase (CARS-DB)
AKI(Acute Kidney Injury) is a common complication after cardiac surgery which is associated with increased mortality and morbidity. Collecting perioperative biosignal data and studying their association with renal outcomes can help improve kidney injury, mortality, and morbidity in cardiac surgical patients. Furthermore, the occurrence of AKI, length of hospital stay, and recovery of renal function after discharge are closely associated with the development of chronic kidney disease (CKD). Therefore, regular monitoring of renal function and related indicators in cardiac surgical patients can help improve long-term outcomes.
- Conditions
- Cardiac Anaesthesia
- Keywords
- Acute Kidney Injury, Cardiovascular Surgical Procedures, Cardiopulmonary Bypass, Biomarker, Biosignal data, Renal outcome
- Medical subject headings
- 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 |
|---|---|---|
| anesthesia for cardiovascular surgery using cardiopulmonary bypass | patients scheduled for cardiovascular surgery with CPB which requires anesthesia in the operating room |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative AKI incidence within 1 week after cardiac surgery with CPB
The definition of AKI refers to Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney Injury.
Measured: within first 7 days after surgery
Secondary outcomes (5)
MAKE 30 (Major adverse kidney event within 30 days)
death, starting dialysis, or decrease in eGFR of 25 % or more within 30 days after surgery
Measured: within 30 days after surgery
MAKE 90 (Major Adverse kidney event within 90 days)
death, starting dialysis, or decrease in eGFR of 25 % or more within 90 days after surgery
Measured: within 90 days after surgery
incidence of CKD (chronic kidney disease) within 1 year
at least one of the following criteria is met, with structural or functional abnormalities of the kidney persisting for at least 3 months within 1 year
- urine albumin/creatinine ratio ≥ 30 mg/g
- abnormality in urine sediment test or persistent hematuria
- renal structural abnormalities found in image study
- eGFR < 60 ml/min/1.73m2 (GFR category G3a-G5)
Measured: within 1 year after surgery
1 year mortality
death due to any cause within 1 year
Measured: within 1 year after surgery
in-hospital mortality
death which occurs during the hospitalization
Measured: from day of hospitalization for surgery until discharge after surgery 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study startSep 2024 (estimated)
- Primary completion1 Aug 2034 (estimated)
- Study completion30 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AnaesthesiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581289
- Sponsor's protocol ID
- 4-2024-0557
- Status last verified
- Aug 2024
- First submitted
- 27 Jun 2024
- Last updated
- 3 Sep 2024
- 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 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Anesthesia Registry Including Biosignal Database for Prognostication of Postoperative Renal Outcome: Cardiac Anesthesia Renal Outcome in Severance Cardiovascular Hospital - DataBase (CARS-DB)
- ClinicalTrials.gov ID
- NCT06581289
- Acronym / sponsor ID
- 4-2024-0557
- Conditions
- Cardiac Anaesthesia
- Keywords
- Acute Kidney Injury, Cardiovascular Surgical Procedures, Cardiopulmonary Bypass, Biomarker, Biosignal data, Renal outcome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- 1 Aug 2034 (estimated)
- Study completion
- 30 Sep 2034 (estimated)
- First posted
- 3 Sep 2024 (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.
AKI(Acute Kidney Injury) is a common complication after cardiac surgery which is associated with increased mortality and morbidity. Collecting perioperative biosignal data and studying their association with renal outcomes can help improve kidney injury, mortality, and morbidity in cardiac surgical patients. Furthermore, the occurrence of AKI, length of hospital stay, and recovery of renal function after discharge are closely associated with the development of chronic kidney disease (CKD). Therefore, regular monitoring of renal function and related indicators in cardiac surgical patients can help improve long-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anesthesia for cardiovascular surgery using cardiopulmonary bypass | – | –patients scheduled for cardiovascular surgery with CPB which requires anesthesia in the operating room |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 19 year and older admitted to Severance cardiovascular hospital for cardiac surgery using CPB (Cardiopulmonary bypass).
Key inclusion criteria (1 listed)
- Aged 19 years and older scheduled for cardiac surgery using CPB
Key exclusion criteria (1 listed)
- emergency operation, the patient is foreigner or illiterate and unable to read the consent form
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
post-operative AKI incidence within 1 week after cardiac surgery with CPB
Time frame: within first 7 days after surgery
The definition of AKI refers to Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney Injury.
5 secondary outcomes
MAKE 30 (Major adverse kidney event within 30 days)
Time frame: within 30 days after surgery
MAKE 90 (Major Adverse kidney event within 90 days)
Time frame: within 90 days after surgery
incidence of CKD (chronic kidney disease) within 1 year
Time frame: within 1 year after surgery
1 year mortality
Time frame: within 1 year after surgery
in-hospital mortality
Time frame: from day of hospitalization for surgery until discharge after surgery 1year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- 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.
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 Cardiac Anaesthesia, 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 1 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: opening soon, as of the sponsor's last update on 3 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative AKI incidence within 1 week after cardiac surgery with CPB (time frame: within first 7 days after surgery). 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 3 Sep 2024.