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

NCT07330453 | Not Yet Recruiting DMC

• 1 other identifier: 2025ZD0547500
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiovascular Surgery

Outcome Measures

Primary Outcomes (1)

• The occurrence of post-operative acute kidney injury

  From the end of surgery to 48 hours postoperative

Secondary Outcomes (2)

• The occurrence of adverse kidney events up to 2 years.

  2 years

• The occurrence of adverse cardiovascular events up to 2 years.

  2 years

Study Arms (2)

Patients who did not develop acute kidney injury(AKI) after cardiovascular surgery

Other: Observation

Patients who developed AKI after cardiovascular surgery

Other: Observation

Interventions

Observation OTHER

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

Patients who developed AKI after cardiovascular surgery; Patients who did not develop acute kidney injury(AKI) after cardiovascular surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100444, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Perioperative Blood and Urine Samples

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Sheng Liu

CONTACT

8613501331366; liusheng@fuwai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 9, 2026
• Study Start: December 25, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

CN (1)