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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese Academy of Medical Sciences, Fuwai Hospital

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 years;

Scheduled to undergo elective cardiac surgery;

Able to complete baseline data collection and provide written informed consent.

Disqualifiers

Preoperative serum creatinine > 353 μmol/L, history of or currently receiving dialysis therapy.

History of kidney transplantation.

Presence of malignant tumors.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observation

    Other intervention

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

Treatment groups

5,000 Participants
are divided into 2 treatment groups
Group A: Patients who did not develop acute kidney injury(AKI) after cardiovascular surgery1 intervention
Group B: Patients who developed AKI after cardiovascular surgery1 intervention

Trial outcomes

Primary outcomes

1

The occurrence of post-operative acute kidney injury

Time frame
From the end of surgery to 48 hours postoperative

Secondary outcomes

1

The occurrence of adverse kidney events up to 2 years.

Time frame
2 years
2

The occurrence of adverse cardiovascular events up to 2 years.

Time frame
2 years

Other outcomes

Sponsors and contacts

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