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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07330453
Enrollment
5000
Registered
2026-01-09
Start date
2025-12-25
Completion date
2029-07-31
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Surgery

Brief summary

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

Interventions

OTHERObservation

As an observational study, patients' therapeutic approach will not be modified during the course of this research.

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
The occurrence of post-operative acute kidney injuryFrom the end of surgery to 48 hours postoperative

Secondary

MeasureTime frame
The occurrence of adverse kidney events up to 2 years.2 years
The occurrence of adverse cardiovascular events up to 2 years.2 years

Countries

China

Contacts

Primary ContactSheng Liu
liusheng@fuwai.com8613501331366

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026