NCT07482683

Brief Summary

Renal injury after cardiac surgery is one of the common complications with high incidence rate, high risk of death and progression to chronic kidney disease (CKD). Previous evaluations of perioperative renal function mainly focused on acute kidney injury (AKI) related to cardiac surgery within seven days after surgery. The newly proposed concept of acute kidney disease (AKD) in recent years refers to acute or subacute kidney injury lasting seven to ninety days. Research has found that AKD can occur after AKI or in patients without AKI, and the two are both related and independent of each other, possibly indicating different subtypes of kidney injury. AKD is not uncommon and is a more significant predictor of mortality and end-stage kidney disease (ESKD). Therefore, AKD may be an important window for identifying and managing high-risk patients after cardiac surgery. Due to limited research on AKD after cardiac surgery, the risk factors for AKD are currently unclear, and there are no clinically practical and effective risk stratification tools available. This study aims to establish a multimodal perioperative data platform through a retrospective cohort, and use machine learning methods to construct a risk prediction model for AKD after cardiac surgery. The accuracy and stability of the model will be validated in a prospective study cohort, and an online risk prediction and clinical decision-making tool will be developed to help clinicians quickly conduct personalized risk assessments and optimize diagnosis and treatment strategies, thereby improving patient prognosis and reducing medical costs.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
820

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress32%
Mar 2026Jun 2027

Study Start

First participant enrolled

March 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 19, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

March 15, 2026

Last Update Submit

March 15, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with acute kidney disease after cardiac surgery Assessed by KDIGO guideline

    within 90 days after cardiac surgery

  • acute kidney disease after cardiac surgery

    within 90 days after cardiac surgery

Study Arms (1)

Adult patients undergoing coronary artery bypass grafting and/or heart valve surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients undergoing cardiac surgery at Fuwai Hospital

You may qualify if:

  • Age ≥ 18 years;
  • Undergoing coronary artery bypass grafting and/or heart valve surgery, with or without aortic surgery;
  • Baseline serum creatinine level \< 354 umol/L;
  • Informed consent obtained.

You may not qualify if:

  • Emergency surgery;
  • Multiple surgeries or reoperation;
  • End-stage kidney disease (ESKD), renal replacement therapy, or kidney transplantation;
  • Occurrence of AKI within 1 week before surgery or unresolved AKI;
  • Death within 1 week after surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center for Cardiovascular Diseases

Beijing, China

Location

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 15, 2026

First Posted

March 19, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

March 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations