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CompletedNCT04172103Updated Oct 22, 2021

The Association Between the Duration of Acute Kidney Injury and New-onset Chronic Kidney Disease After Cardiac or Thoracic Aortic Surgery

An observational study in Acute Kidney Injury, Chronic Kidney Disease, Stage 3 and Chronic Kidney Disease, Stage 5, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-10-22.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,009
Ages
20 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • 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
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In context

Acute Kidney Injury

1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.

This study's enrollment of 2,009 is above the median of 156 across 795 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients who underwent cardiac or thoracic aortic surgery under cardiopulmonary bypass at Seoul National University Hospital between 2008 and 2017

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,009 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: during 3 years after surgery

Secondary outcomes

  1. 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

    Time frame: during 1 year after surgery

  2. 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

    Time frame: during 2 years after surgery

  3. Length of postoperative hospital stay

    Length of postoperative hospital stay

    Time frame: during one month after surgery

  4. Length of postoperative intensive care unit stay

    Length of postoperative intensive care unit stay

    Time frame: during one month after surgery

  5. intra-aortic balloon pulsation insertion

    intra-aortic balloon pulsation insertion

    Time frame: during surgery and postoperative one week

  6. Reopen for surgical bleeding

    Reopen for surgical bleeding

    Time frame: during one month after surgery

  7. Respiratory complication

    a composite outcome including postoperative atelectasis, pneumonia, pulmonary edema, pleural effusion and pneumothorax

    Time frame: during one month after surgery

  8. in-hospital mortality

    all-cause mortality during hospital stay

    Time frame: during one month after surgery

  9. Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2

    Incidence of estimated Glomerular Filtration Rate \<60 mL/min/1.73m2

    Time frame: at three months after surgery

  10. Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2

    Incidence of estimated Glomerular Filtration Rate \<60 mL/min/1.73m2

    Time frame: at one year after surgery

  11. Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2

    Incidence of estimated Glomerular Filtration Rate \<60 mL/min/1.73m2

    Time frame: at two years after surgery

  12. Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2

    Incidence of estimated Glomerular Filtration Rate \<60 mL/min/1.73m2

    Time frame: at three years after surgery

  13. Dependence on the regular hemodialysis

    Dependence on the regular hemodialysis

    Time frame: at three years after surgery

  14. estimated Glomerular Filtration Rate

    estimated Glomerular Filtration Rate

    Time frame: at three months after surgery

  15. estimated Glomerular Filtration Rate

    estimated Glomerular Filtration Rate

    Time frame: at one year after surgery

  16. estimated Glomerular Filtration Rate

    estimated Glomerular Filtration Rate

    Time frame: at two years after surgery

  17. estimated Glomerular Filtration Rate

    estimated Glomerular Filtration Rate

    Time frame: at three years after surgery

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Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, South Korea
08

References and documents

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 28869251 ↗
  • Chawla 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2019 to primary completion in Dec 2020, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2019
First posted
Nov 21, 2019
StartActual
Nov 19, 2019
Primary completionActual
Dec 1, 2020
CompletionActual
Dec 1, 2020
Last update
Oct 22, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04172103
Responsible party
Sponsor
First posted
Nov 21, 2019
Start date
Nov 19, 2019
Primary completion
Dec 1, 2020
Completion
Dec 1, 2020
Last update
Oct 22, 2021

Study contacts

Won Ho Kim, MD, PhD
principal investigator · Associate Professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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