Predicting Poor Outcomes of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers

NCT ID: NCT04962412

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-12

Study Completion Date

2025-05-31

Brief Summary

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The aim of this study was to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.

Detailed Description

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Cardiac surgery-associated acute kidney injury (CSA-AKI) is the second most common type of AKI after septic AKI and is associated with increased mortality and morbidity. The progression of AKI with multiple organ failure can result in poor outcomes. Several novel biomarkers for earlier detection of AKI, discrimination of etiologies, and prediction of outcomes were developed. However, the availability of these novel biomarkers may be limited by its expense or reimbursement issues in different countries. In present study, we conduct a large cohort to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.

Conditions

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Acute Kidney Injury Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Standard care "bundle"

The management for AKI patients were performed by implementing a standard care "bundle" suggested by the Kidney Disease Improving Global Outcome (KDIGO) guideline.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing cardiac surgery were prospectively screened, and those who developed AKI within 48 hours post-surgery were included in the study.

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

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guowei Tu

OTHER

Sponsor Role lead

Responsible Party

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Guowei Tu

Scientific Secretary for Department of Critical Care Medcine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhe Luo, Professor

Role: STUDY_DIRECTOR

Fudan University

Locations

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Zhongshan hospital, Fudan university

Shanghai, , China

Site Status

Countries

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China

References

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Su Y, Liu WJ, Zhao YF, Zhang YJ, Qiu Y, Lu ZH, Wang P, Lin S, Tu GW, Luo Z. Modified furosemide responsiveness index and biomarkers for AKI progression and prognosis: a prospective observational study. Ann Intensive Care. 2024 Oct 8;14(1):156. doi: 10.1186/s13613-024-01387-y.

Reference Type DERIVED
PMID: 39379672 (View on PubMed)

Other Identifiers

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B2021-390R

Identifier Type: -

Identifier Source: org_study_id

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