Acute Kidney InjuryNCT04172103
The Association Between the Duration of Acute Kidney Injury and New-onset Chronic Kidney Disease After Cardiac or Thoracic Aortic Surgery
An observational study of Acute Kidney Injury and Chronic Kidney Disease, Stage 3, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators aimed to evaluate the association between the duration and stage of acute kidney injury (AKI) and the development of chronic kidney disease during postoperative three years in patients undergoing cardiac or thoracic aortic surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Disease, Stage 3, Chronic Kidney Disease, Stage 5
- How many people
- 2,009 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Nov 2019to 1 Dec 2020
- 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
- Adult, Older adult
Study population: A retrospective cohort of the adult patients who underwent cardiac or thoracic aortic surgery under cardiopulmonary bypass at Seoul National University Hospital between 2008 and 2017
Who may be able to join
- Adult patients who underwent cardiac or thoracic aortic surgery under cardiopulmonary bypass at Seoul National University Hospital between 2008 and 2017
Who cannot join
- Those with off-pump coronary artery bypass
- Missing baseline serum creatinine
- Missing postoperative serum creatinine values of more than three among seven postoperative days
- Preoperative baseline chronic kidney disease with estimated glomerular filtration rate <60 ml/min/1.73m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between the Duration of Acute Kidney Injury and New-onset Chronic Kidney Disease After Cardiac or Thoracic Aortic Surgery: a Retrospective Observational Cohort Study
The investigators aimed to evaluate the association between the duration and stage of acute kidney injury (AKI) and the development of chronic kidney disease during postoperative three years in patients undergoing cardiac or thoracic aortic surgery.
Read the detailed description
Postoperative acute kidney injury (AKI) has been investigated as an important contributor to postoperative morbidity and mortality after cardiovascular surgery. Also, temporary worsening of renal function after aortic surgery is associated with higher long-term mortality. Although the associations between AKI and chronic kidney disease (CKD) in medical or other surgical settings were reported, only a few studies evaluated this relationship in patients undergoing cardiac surgery. More specifically, the association of the severity or duration of AKI with the risk of the development of new-onset CKD after cardiac surgery has not been clearly elucidated.
It would be important to find predictors of the long-term renal function or risk factors for the development of CKD after cardiac surgery because postoperative management of high-risk patients to develop long-term renal dysfunction may prevent further deterioration in renal function and improve patient prognosis.
The investigators aimed to evaluate (1) the long-term renal function after cardiac surgery and (2) the association between the duration and stage of acute kidney injury (AKI) and the development of chronic kidney disease during postoperative three years in patients undergoing cardiac or thoracic aortic surgery.
- Conditions
- Acute Kidney Injury, Chronic Kidney Disease, Stage 3, Chronic Kidney Disease, Stage 5, Cardiac Surgery, Thoracic Aortic Surgery
- Keywords
- acute kidney injury, chronic kidney disease, cardiac surgery, thoracic aortic surgery
- 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.
new-onset chronic kidney disease stage 3 or higher or mortality
development of new-onset chronic kidney disease stage 3 or higher or all-cause mortality developed during 3 years after surgery. The new-onset chronic kidney disease was defined by at least two estimated Glomerular Filtration Rate values <60 ml/min/1.73 m2 separated by an interval of at least three months.
Measured: during 3 years after surgery
Secondary outcomes (17)
new-onset chronic kidney disease stage 3 or higher or mortality
development of new-onset chronic kidney disease stage 3 or higher or all-cause mortality developed during 1 year after surgery
Measured: during 1 year after surgery
new-onset chronic kidney disease stage 3 or higher or mortality
development of new-onset chronic kidney disease stage 3 or higher or all-cause mortality developed during 2 years after surgery
Measured: during 2 years after surgery
Length of postoperative hospital stay
Length of postoperative hospital stay
Measured: during one month after surgery
Length of postoperative intensive care unit stay
Length of postoperative intensive care unit stay
Measured: during one month after surgery
intra-aortic balloon pulsation insertion
intra-aortic balloon pulsation insertion
Measured: during surgery and postoperative one week
Reopen for surgical bleeding
Reopen for surgical bleeding
Measured: during one month after surgery
Respiratory complication
a composite outcome including postoperative atelectasis, pneumonia, pulmonary edema, pleural effusion and pneumothorax
Measured: during one month after surgery
in-hospital mortality
all-cause mortality during hospital stay
Measured: during one month after surgery
Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
Measured: at three months after surgery
Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
Measured: at one year after surgery
Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
Measured: at two years after surgery
Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
Measured: at three years after surgery
Dependence on the regular hemodialysis
Dependence on the regular hemodialysis
Measured: at three years after surgery
estimated Glomerular Filtration Rate
estimated Glomerular Filtration Rate
Measured: at three months after surgery
estimated Glomerular Filtration Rate
estimated Glomerular Filtration Rate
Measured: at one year after surgery
estimated Glomerular Filtration Rate
estimated Glomerular Filtration Rate
Measured: at two years after surgery
estimated Glomerular Filtration Rate
estimated Glomerular Filtration Rate
Measured: at three years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start19 Nov 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 2,009 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Won Ho Kim, MD, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172103
- Sponsor's protocol ID
- 1909-115-1066
- Status last verified
- Oct 2021
- First submitted
- 19 Nov 2019
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Y, Bellomo R. Cardiac surgery-associated acute kidney injury: risk factors, pathophysiology and treatment. Nat Rev Nephrol. 2017 Nov;13(11):697-711. doi: 10.1038/nrneph.2017.119. Epub 2017 Sep 4.
PubMed 28869251Chawla LS, Eggers PW, Star RA, Kimmel PL. Acute kidney injury and chronic kidney disease as interconnected syndromes. N Engl J Med. 2014 Jul 3;371(1):58-66. doi: 10.1056/NEJMra1214243. No abstract available.
PubMed 24988558
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between the Duration of Acute Kidney Injury and New-onset Chronic Kidney Disease After Cardiac or Thoracic Aortic Surgery: a Retrospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04172103
- Acronym / sponsor ID
- 1909-115-1066
- Conditions
- Acute Kidney Injury, Chronic Kidney Disease, Stage 3, Chronic Kidney Disease, Stage 5, Cardiac Surgery, Thoracic Aortic Surgery
- Keywords
- acute kidney injury, chronic kidney disease, cardiac surgery, thoracic aortic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,009 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 21 Nov 2019 (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.
The investigators aimed to evaluate the association between the duration and stage of acute kidney injury (AKI) and the development of chronic kidney disease during postoperative three years in patients undergoing cardiac or thoracic aortic surgery.
Detailed description
Postoperative acute kidney injury (AKI) has been investigated as an important contributor to postoperative morbidity and mortality after cardiovascular surgery. Also, temporary worsening of renal function after aortic surgery is associated with higher long-term mortality. Although the associations between AKI and chronic kidney disease (CKD) in medical or other surgical settings were reported, only a few studies evaluated this relationship in patients undergoing cardiac surgery. More specifically, the association of the severity or duration of AKI with the risk of the development of new-onset CKD after cardiac surgery has not been clearly elucidated.
It would be important to find predictors of the long-term renal function or risk factors for the development of CKD after cardiac surgery because postoperative management of high-risk patients to develop long-term renal dysfunction may prevent further deterioration in renal function and improve patient prognosis.
The investigators aimed to evaluate (1) the long-term renal function after cardiac surgery and (2) the association between the duration and stage of acute kidney injury (AKI) and the development of chronic kidney disease during postoperative three years in patients undergoing cardiac or thoracic aortic surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A retrospective cohort of the adult patients who underwent cardiac or thoracic aortic surgery under cardiopulmonary bypass at Seoul National University Hospital between 2008 and 2017
Key inclusion criteria (1 listed)
- Adult patients who underwent cardiac or thoracic aortic surgery under cardiopulmonary bypass at Seoul National University Hospital between 2008 and 2017
Key exclusion criteria (4 listed)
- Those with off-pump coronary artery bypass
- Missing baseline serum creatinine
- Missing postoperative serum creatinine values of more than three among seven postoperative days
- Preoperative baseline chronic kidney disease with estimated glomerular filtration rate <60 ml/min/1.73m2
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
new-onset chronic kidney disease stage 3 or higher or mortality
Time frame: during 3 years after surgery
development of new-onset chronic kidney disease stage 3 or higher or all-cause mortality developed during 3 years after surgery. The new-onset chronic kidney disease was defined by at least two estimated Glomerular Filtration Rate values <60 ml/min/1.73 m2 separated by an interval of at least three months.
17 secondary outcomes
new-onset chronic kidney disease stage 3 or higher or mortality
Time frame: during 1 year after surgery
new-onset chronic kidney disease stage 3 or higher or mortality
Time frame: during 2 years after surgery
Length of postoperative hospital stay
Time frame: during one month after surgery
Length of postoperative intensive care unit stay
Time frame: during one month after surgery
intra-aortic balloon pulsation insertion
Time frame: during surgery and postoperative one week
Reopen for surgical bleeding
Time frame: during one month after surgery
Respiratory complication
Time frame: during one month after surgery
in-hospital mortality
Time frame: during one month after surgery
Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
Time frame: at three months after surgery
Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
Time frame: at one year after surgery
Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
Time frame: at two years after surgery
Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
Time frame: at three years after surgery
Dependence on the regular hemodialysis
Time frame: at three years after surgery
estimated Glomerular Filtration Rate
Time frame: at three months after surgery
estimated Glomerular Filtration Rate
Time frame: at one year after surgery
estimated Glomerular Filtration Rate
Time frame: at two years after surgery
estimated Glomerular Filtration Rate
Time frame: at three years after surgery
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 22 Oct 2021.
- Background: PubMed 28869251Wang Y, Bellomo R. Cardiac surgery-associated acute kidney injury: risk factors, pathophysiology and treatment. Nat Rev Nephrol. 2017 Nov;13(11):697-711. doi: 10.1038/nrneph.2017.119. Epub 2017 Sep 4.
- Background: PubMed 24988558Chawla LS, Eggers PW, Star RA, Kimmel PL. Acute kidney injury and chronic kidney disease as interconnected syndromes. N Engl J Med. 2014 Jul 3;371(1):58-66. doi: 10.1056/NEJMra1214243. No abstract available.
- Statistical analysis planLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Won Ho Kim, MD, PhD principal investigator
Associate Professor
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 Chronic Kidney Disease, Stage 3, run by Seoul National University Hospital 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 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 22 Oct 2021. 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?
new-onset chronic kidney disease stage 3 or higher or mortality (time frame: during 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04172103, which also lists 2 linked publications.
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 22 Oct 2021.