Cardiovascular Surgery Early Prediction System for AKI :CARDS-AKI Registry

January 4, 2026 updated by: Sheng Liu, Chinese Academy of Medical Sciences, Fuwai Hospital

Early Prediction and Clinical Outcomes of Cardiovascular Surgery-Associated Acute Kidney Injury: A Prospective Multicenter Cohort Study

This multicenter, prospective study prospectively enrolled patients undergoing cardiovascular surgery. Detailed perioperative clinical data and biospecimens were collected at multiple time points. The primary aim is to develop an early warning model for postoperative acute kidney injury (AKI) by integrating clinical data and biomarkers. Additionally, through long-term follow-up, the study seeks to characterize outcome trajectories and establish a prognostic model for AKI patients.

This study addresses four key questions: 1) Integration of clinical information and biomarkers to develop an early predictive model for cardiac surgery-associated acute kidney injury (CSA-AKI); 2) Identification of risk factors for CSA-AKI occurrence; 3) Determinants of prognosis in patients with CSA-AKI; and 4) Enhanced prediction of near- and long-term clinical event risks in this patient population.

Participants will receive standard perioperative management. The study protocol includes the following procedures:(1) Clinical Data Collection: Comprehensive perioperative clinical data will be systematically recorded. (2) Biospecimen Sampling: Serial blood and urine samples will be obtained at predefined time points throughout the perioperative period. (3) In-Hospital Monitoring: Clinical outcomes will be continuously monitored during the hospital stay. (3) Post-discharge Follow-up: Participants will be assessed at regular intervals after discharge to track the occurrence of major adverse events.

These findings provide a foundational basis for the development of a data-driven early-warning system. Such a system is designed to facilitate the prompt identification of high-risk patients and enable the initiation of personalized treatment strategies, thereby potentially improving clinical outcomes and optimizing resource allocation

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100444
        • Fuwai Hospital, Chinese Academy of Medical Science
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Fuwai Hospital, CAMS & PUMC, Peking University People's Hospital; Guangdong People's Hospital; Fuwai Hospital Shenzhen (Sun Yat-sen Cardiovascular Hospital, Shenzhen); Huaxi Hospital, Sichuan University; Yantai Yuhuangding Hospital; Fuwai Centarl China Cardiovascular Hospital; Fuwai Yunnan Hospital, Academy of Medical Science; Yinzhou District Center for Disease Control and Prevention, Ningbo; Peking University First Hospital

Description

Inclusion Criteria:

  • Age ≥ 18 years；
  • Scheduled to undergo elective cardiac surgery；
  • Able to complete baseline data collection and provide written informed consent.

Exclusion Criteria:

  • Preoperative serum creatinine > 353 μmol/L, history of or currently receiving dialysis therapy.
  • History of kidney transplantation.
  • Presence of malignant tumors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who did not develop acute kidney injury(AKI) after cardiovascular surgery
Other: Observation
As an observational study, patients' therapeutic approach will not be modified during the course of this research.
Patients who developed AKI after cardiovascular surgery
Other: Observation
As an observational study, patients' therapeutic approach will not be modified during the course of this research.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The occurrence of post-operative acute kidney injury
Time Frame: From the end of surgery to 48 hours postoperative
From the end of surgery to 48 hours postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
The occurrence of adverse kidney events up to 2 years.
Time Frame: 2 years
2 years
The occurrence of adverse cardiovascular events up to 2 years.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 25, 2025

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

July 31, 2029

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

January 4, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025ZD0547500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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