Acute Kidney InjuryNCT05577039
Preoperative RRI and Long-term Risk for CKD
An observational study of Acute Kidney Injury and Acute Kidney Disease, run by Region Stockholm at 1 site in Sweden.
Trial summary
Renal resistive index (RRI) is calculated from ultrasonographic Doppler measurements of flow velocities in intraparenchymal renal arteries. Normal values are around 0.60, and 0.70 is considered the upper normal threshold in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Acute Kidney Disease, Chronic Kidney Disease
- How many people
- 96 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2022to 1 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective cardiac surgery patients
Who may be able to join
- Age ≥18
- Elective coronary artery bypass grafting, heart valve surgery, or aortic surgery performed at Karolinska University Hospital between September 2014 and April 2015
- Preoperative measurement of RRI performed with satisfactory Doppler reading
- Written informed consent
Who cannot join
- Kidney transplant
- Dialysis-dependent kidney disease
- Cancelled surgery
- Missing follow-up data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Renal Resistive Index to Predict Long-term Development of Chronic Kidney Disease in Patients Undergoing Cardiac Surgery
Renal resistive index (RRI) is calculated from ultrasonographic Doppler measurements of flow velocities in intraparenchymal renal arteries. Normal values are around 0.60, and 0.70 is considered the upper normal threshold in adults. Both preoperative and postoperative elevation of RRI has shown promise in early detection of AKI after cardiac surgery. Further, elevated RRI before coronary angiography is associated with an increased risk of cardiovascular complications up to 1 year after the procedure. The role of preoperative RRI in predicting long-term renal and cardiovascular complications after elective surgery is however not known. The aim of this study is to assess the role of preoperative RRI to predict the risk of persistent renal dysfunction as well as renal- and cardiovascular complications up to 5 years after surgery.
- Conditions
- Acute Kidney Injury, Acute Kidney Disease, Chronic Kidney Disease, Cardiac Surgery, Renal Resistive Index
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term renal dysfunction
Reduced estimated glomerular filtration rate (eGFR) ≥25% from baseline
Measured: 5 years after surgery or end of follow-up
Secondary outcomes (4)
Short-term renal dysfunction
Reduced eGFR ≥25% from baseline
Measured: 30 days after surgery
Intermediate renal dysfunction
Reduced eGFR ≥25% from baseline
Measured: 90 days after surgery
Major adverse kidney events (MAKE)
Composite outcome during follow-up time including one of; death, renal replacement therapy, reduced eGFR ≥25% from baseline
Measured: 30 days, 90 days, 1 year, and 5 years after surgery or end of follow-up
Major adverse cardiac and cerebrovascular events (MACCE)
Composite outcome during follow-up time including one of; death, myocardial infarction, heart failure, stroke
Measured: 30 days, 90 days, 1 year, and 5 years after surgery or end of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Nov 2022
- Primary completion1 Jun 2023
- Study completion1 Sep 2023
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 Region StockholmThe 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
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Daniel Hertzberg, M.D., Principal investigator, Department of Perioperative Medicine and Intensive Care, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577039
- Sponsor's protocol ID
- K 2021-9906
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Renal Resistive Index to Predict Long-term Development of Chronic Kidney Disease in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05577039
- Acronym / sponsor ID
- K 2021-9906
- Conditions
- Acute Kidney Injury, Acute Kidney Disease, Chronic Kidney Disease, Cardiac Surgery, Renal Resistive Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 13 Oct 2022 (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.
Renal resistive index (RRI) is calculated from ultrasonographic Doppler measurements of flow velocities in intraparenchymal renal arteries. Normal values are around 0.60, and 0.70 is considered the upper normal threshold in adults. Both preoperative and postoperative elevation of RRI has shown promise in early detection of AKI after cardiac surgery. Further, elevated RRI before coronary angiography is associated with an increased risk of cardiovascular complications up to 1 year after the procedure. The role of preoperative RRI in predicting long-term renal and cardiovascular complications after elective surgery is however not known. The aim of this study is to assess the role of preoperative RRI to predict the risk of persistent renal dysfunction as well as renal- and cardiovascular complications up to 5 years after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective cardiac surgery patients
Key inclusion criteria (4 listed)
- Age ≥18
- Elective coronary artery bypass grafting, heart valve surgery, or aortic surgery performed at Karolinska University Hospital between September 2014 and April 2015
- Preoperative measurement of RRI performed with satisfactory Doppler reading
- Written informed consent
Key exclusion criteria (4 listed)
- Kidney transplant
- Dialysis-dependent kidney disease
- Cancelled surgery
- Missing follow-up data
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
Long-term renal dysfunction
Time frame: 5 years after surgery or end of follow-up
Reduced estimated glomerular filtration rate (eGFR) ≥25% from baseline
4 secondary outcomes
Short-term renal dysfunction
Time frame: 30 days after surgery
Intermediate renal dysfunction
Time frame: 90 days after surgery
Major adverse kidney events (MAKE)
Time frame: 30 days, 90 days, 1 year, and 5 years after surgery or end of follow-up
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 30 days, 90 days, 1 year, and 5 years after surgery or end of follow-up
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 24 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Hertzberg, M.D. principal investigator
Department of Perioperative Medicine and Intensive Care, Karolinska University Hospital
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 Acute Kidney Injury and Acute Kidney Disease, run by Region Stockholm at 1 site in Sweden.
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 4 inclusion and 4 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 24 Nov 2023. 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 Sweden. 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?
Long-term renal dysfunction (time frame: 5 years after surgery or end of follow-up). 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 24 Nov 2023.