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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04172103
Collaborator
(none)
2,009
1
12.4
161.8

Study Details

Study Description

Brief 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.

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

Study Type:
Observational
Actual Enrollment :
2009 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
Nov 19, 2019
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 1, 2020

Outcome Measures

Primary Outcome Measures

  1. new-onset chronic kidney disease stage 3 or higher or mortality [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.

Secondary Outcome Measures

  1. new-onset chronic kidney disease stage 3 or higher or mortality [during 1 year after surgery]

    development of new-onset chronic kidney disease stage 3 or higher or all-cause mortality developed during 1 year after surgery

  2. new-onset chronic kidney disease stage 3 or higher or mortality [during 2 years after surgery]

    development of new-onset chronic kidney disease stage 3 or higher or all-cause mortality developed during 2 years after surgery

  3. Length of postoperative hospital stay [during one month after surgery]

    Length of postoperative hospital stay

  4. Length of postoperative intensive care unit stay [during one month after surgery]

    Length of postoperative intensive care unit stay

  5. intra-aortic balloon pulsation insertion [during surgery and postoperative one week]

    intra-aortic balloon pulsation insertion

  6. Reopen for surgical bleeding [during one month after surgery]

    Reopen for surgical bleeding

  7. Respiratory complication [during one month after surgery]

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

  8. in-hospital mortality [during one month after surgery]

    all-cause mortality during hospital stay

  9. Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2 [at three months after surgery]

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

  10. Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2 [at one year after surgery]

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

  11. Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2 [at two years after surgery]

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

  12. Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2 [at three years after surgery]

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

  13. Dependence on the regular hemodialysis [at three years after surgery]

    Dependence on the regular hemodialysis

  14. estimated Glomerular Filtration Rate [at three months after surgery]

    estimated Glomerular Filtration Rate

  15. estimated Glomerular Filtration Rate [at one year after surgery]

    estimated Glomerular Filtration Rate

  16. estimated Glomerular Filtration Rate [at two years after surgery]

    estimated Glomerular Filtration Rate

  17. estimated Glomerular Filtration Rate [at three years after surgery]

    estimated Glomerular Filtration Rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Principal Investigator: Won Ho Kim, MD, PhD, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04172103
Other Study ID Numbers:
  • 1909-115-1066
First Posted:
Nov 21, 2019
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seoul National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2021