NCT04172103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,009

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

November 19, 2019

Last Update Submit

October 20, 2021

Conditions

Keywords

acute kidney injurychronic kidney diseasecardiac surgerythoracic aortic surgery

Outcome Measures

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.

    during 3 years after surgery

Secondary Outcomes (17)

  • new-onset chronic kidney disease stage 3 or higher or mortality

    during 1 year after surgery

  • new-onset chronic kidney disease stage 3 or higher or mortality

    during 2 years after surgery

  • Length of postoperative hospital stay

    during one month after surgery

  • Length of postoperative intensive care unit stay

    during one month after surgery

  • intra-aortic balloon pulsation insertion

    during surgery and postoperative one week

  • +12 more secondary outcomes

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 28869251BACKGROUND
  • 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.

    PMID: 24988558BACKGROUND

Related Links

MeSH Terms

Conditions

Acute Kidney InjuryRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Won Ho Kim, MD, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 21, 2019

Study Start

November 19, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations