Acute Kidney InjuryNCT06464666
Association Between Renal Resistive Index(RRI) and AKI(Acute Kidney Injury) in Cardiac Surgery Patients With Cardiopulmonary Bypass (CPB)
An observational study of Acute Kidney Injury and Renal Resistive Index, run by Yonsei University.
Trial summary
AKI(Acute Kidney Injury) is a common complication after cardiac surgery which is associated with increased mortality and morbidity. The conventiional marker for detecting AKI is serum creatinine, however, which has many limits. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Acute Kidney Injury, Renal Resistive Index
- What is being tested?
- Renal interlobar artery US and Renal inter-lobular artery US
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 30 Jun 2025
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Association between renal resistive index(RRI) and AKI(Acute Kidney Injury) in cardiac surgery patients
Who may be able to join
- Aged 19 years and older scheduled for cardiac surgery using CPB
Who cannot join
- Emergency opeartion, pre-operative shock status requiring vasopressor or inotropics, s/p kidney transplant patients, CKD stage 4 and 5 patients, patients who have renal artery stenosis or history of renal artery stent implantation, patients who have ascites with Child-Pugh classification B or C, In case of CPB weaning failure, In case of poor lung function and PaO2 or PaCO2 cannot be maintained within normal range.
Trial locations and contacts
No sites are listed yet.
About this study
AKI(Acute Kidney Injury) is a common complication after cardiac surgery which is associated with increased mortality and morbidity. The conventiional marker for detecting AKI is serum creatinine, however, which has many limits. RRI(Renal Resistive Index) is a non-invasive test measured by ultrasound and could be a useful tool to evaulate renal insult in the early phase. Early detection of renal insult and prevention of progression to AKI can contribute to reduing mortality and morbidity in cardiac surgical patients.
- Conditions
- Acute Kidney Injury, Renal Resistive Index
- Being tested
- Renal interlobar artery US, Renal inter-lobular artery US
- 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.
Renal interlobar artery USProcedure or surgery
By using convex US transducer, first find interlobar artery. Then get a pulsed wave doppler at renal interlobar artery for similar 3 to 5 waveforms. Measure peak systolic and minimum diastolic velocity and calculate RRI value.
Renal inter-lobular artery USProcedure or surgery
By using convex US transducer, first find interlobar artery. Then get a pulsed wave doppler at renal interlobar artery for similar 3 to 5 waveforms. Measure peak systolic and minimum diastolic velocity and calculate RRI value.
| Study group | Role | What they receive |
|---|---|---|
| RRI positive group | RRI value higher than 0.7 measured by renal interlobar artery US Receives: Procedure: Renal interlobar artery US | |
| RRI negative group | RRI value lower than 0.7 measured by renal interlobar artery US Receives: Procedure: Renal inter-lobular artery US |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative AKI incidence
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 1 week after surgery
Secondary outcomes (1)
Major adverse kidney outcome (MAKE) 30
MAKE30 includes new dialysis, eGFR decrease more than 25% from the baseline, and mortality
Measured: within first 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion25 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- 250 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
- NCT06464666
- Sponsor's protocol ID
- 4-2024-0439
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Renal Resistive Index(RRI) and AKI(Acute Kidney Injury) in Cardiac Surgery Patients With Cardiopulmonary Bypass (CPB)
- ClinicalTrials.gov ID
- NCT06464666
- Acronym / sponsor ID
- 4-2024-0439
- Conditions
- Acute Kidney Injury, Renal Resistive Index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 25 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 Jun 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. The conventiional marker for detecting AKI is serum creatinine, however, which has many limits. RRI(Renal Resistive Index) is a non-invasive test measured by ultrasound and could be a useful tool to evaulate renal insult in the early phase. Early detection of renal insult and prevention of progression to AKI can contribute to reduing mortality and morbidity in cardiac surgical patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RRI positive group | – | Procedure: Renal interlobar artery USRRI value higher than 0.7 measured by renal interlobar artery US |
| RRI negative group | – | Procedure: Renal inter-lobular artery USRRI value lower than 0.7 measured by renal interlobar artery US |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Association between renal resistive index(RRI) and AKI(Acute Kidney Injury) in cardiac surgery patients
Key inclusion criteria (1 listed)
- Aged 19 years and older scheduled for cardiac surgery using CPB
Key exclusion criteria (1 listed)
- Emergency opeartion, pre-operative shock status requiring vasopressor or inotropics, s/p kidney transplant patients, CKD stage 4 and 5 patients, patients who have renal artery stenosis or history of renal artery stent implantation, patients who have ascites with Child-Pugh classification B or C, In case of CPB weaning failure, In case of poor lung function and PaO2 or PaCO2 cannot be maintained within normal range.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal interlobar artery USBy using convex US transducer, first find interlobar artery. Then get a pulsed wave doppler at renal interlobar artery for similar 3 to 5 waveforms. Measure peak systolic and minimum diastolic velocity and calculate RRI value. | Procedure or surgery | RRI positive group |
| Renal inter-lobular artery USBy using convex US transducer, first find interlobar artery. Then get a pulsed wave doppler at renal interlobar artery for similar 3 to 5 waveforms. Measure peak systolic and minimum diastolic velocity and calculate RRI value. | Procedure or surgery | RRI negative group |
Primary outcome
post-operative AKI incidence
Time frame: within first 1 week 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.
1 secondary outcome
Major adverse kidney outcome (MAKE) 30
Time frame: within first 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Renal Resistive Index, run by Yonsei University.
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: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SUNGMIN SUH, MD (82-10-8916-5701, suh5701@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative AKI incidence (time frame: within first 1 week 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 18 Jun 2024.