Skip to main content
OpenTrials
Completed

NCT Number: NCT04172103

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Kidney Injury Cardiac Surgery Chronic Disease Chronic Kidney Disease, Stage 3 Chronic Kidney Disease, Stage 5 Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Thoracic Aortic Surgery Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: during one month after surgery

    Length of postoperative hospital stay

  4. Length of postoperative intensive care unit stay

    Time frame: during one month after surgery

    Length of postoperative intensive care unit stay

  5. intra-aortic balloon pulsation insertion

    Time frame: during surgery and postoperative one week

    intra-aortic balloon pulsation insertion

  6. Reopen for surgical bleeding

    Time frame: during one month after surgery

    Reopen for surgical bleeding

  7. Respiratory complication

    Time frame: during one month after surgery

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

  8. in-hospital mortality

    Time frame: during one month after surgery

    all-cause mortality during hospital stay

  9. 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

  10. 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

  11. 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

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

    Time frame: at three years after surgery

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

  13. Dependence on the regular hemodialysis

    Time frame: at three years after surgery

    Dependence on the regular hemodialysis

  14. estimated Glomerular Filtration Rate

    Time frame: at three months after surgery

    estimated Glomerular Filtration Rate

  15. estimated Glomerular Filtration Rate

    Time frame: at one year after surgery

    estimated Glomerular Filtration Rate

  16. estimated Glomerular Filtration Rate

    Time frame: at two years after surgery

    estimated Glomerular Filtration Rate

  17. estimated Glomerular Filtration Rate

    Time frame: at three years after surgery

    estimated Glomerular Filtration Rate

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 21, 2019
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.