Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers

NCT ID: NCT06351813

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 358 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2027-12-31

Brief Summary

The aim of this study was to identify and validate novel biomarkers for predict acute kidney injury (AKI) subphenotype, major adverse kidney events and other poor outcomes.

Detailed Description

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a serious condition that is associated with increased mortality and morbidity. However, the current criteria for assessing the severity of AKI may not adequately capture the heterogeneity of this condition. This can lead to difficulties in identifying treatment effects in specific patient subgroups, which may contribute to the growing number of negative interventional trials in AKI. To address this issue, researchers have developed and validated two subphenotypes of AKI: resolving and nonresolving. These subphenotypes are based on the trajectory of serum creatinine (SCr) levels in the first 3 days after hospital presentation. By stratifying AKI patients based on these subphenotypes, we can better assess their risk and predict outcomes.

Several novel biomarkers have been developed to aid in the early detection of AKI, discrimination of its underlying causes, and prediction of outcomes. However, it remains unclear whether these biomarkers can accurately predict the development of a nonresolving AKI subphenotype. In our present study, we aim to address this gap in knowledge by conducting a large cohort study. Our goal is to identify and validate novel biomarkers that can effectively detect the resolving subphenotype of AKI, as well as predict major adverse kidney events and other poor outcomes.

Conditions

Acute Kidney Injury; Critical Illness; Kidney Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing cardiac surgery who experienced AKI within 48 hours of cardiac surgery were screened.

Exclusion Criteria

• History of End Stage Renal Disease or on Dialysis;
• prior kidney transplantation;
• patients with a DNR order;
• patients without written informed consent;
• pregnancy;
• moribund patients with expected death within 24 h or whose survival to 28 days was unlikely due to an uncontrollable comorbidity (i.e., end-stage liver or heart disease, untreatable malignancy)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Hospital (Xiamen), Fudan University

OTHER

Sponsor Role: collaborator

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guowei Tu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhe Luo, Professor

Role: STUDY_DIRECTOR

Fudan University

Locations

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Ying Su, Dr.

Role: CONTACT

su.ying@zs-hospital.sh.cn

+86-021-64041990

Other Identifiers

B2024-029R

Identifier Type: -

Identifier Source: org_study_id