Clinical trial NCT04172103: The Association Between the Duration of Acute Kidney Injury and New-onset Chronic Kidney Disease After Cardiac or Thoracic Aortic Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 2009
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: new-onset chronic kidney disease stage 3 or higher or mortality
timeFrame: during 3 years after surgery
Secondary outcomes:
measure: new-onset chronic kidney disease stage 3 or higher or mortality
timeFrame: during 1 year after surgery
measure: new-onset chronic kidney disease stage 3 or higher or mortality
timeFrame: during 2 years after surgery
measure: Length of postoperative hospital stay
timeFrame: during one month after surgery
measure: Length of postoperative intensive care unit stay
timeFrame: during one month after surgery
measure: intra-aortic balloon pulsation insertion
timeFrame: during surgery and postoperative one week
measure: Reopen for surgical bleeding
timeFrame: during one month after surgery
measure: Respiratory complication
timeFrame: during one month after surgery
measure: in-hospital mortality
timeFrame: during one month after surgery
measure: Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
timeFrame: at three months after surgery
measure: Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
timeFrame: at one year after surgery
measure: Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
timeFrame: at two years after surgery
measure: Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2
timeFrame: at three years after surgery
measure: Dependence on the regular hemodialysis
timeFrame: at three years after surgery
measure: estimated Glomerular Filtration Rate
timeFrame: at three months after surgery
measure: estimated Glomerular Filtration Rate
timeFrame: at one year after surgery
measure: estimated Glomerular Filtration Rate
timeFrame: at two years after surgery
measure: estimated Glomerular Filtration Rate
timeFrame: at three years after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Associate Professor
name: Won Ho Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.