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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04962412
Enrollment
3152
Registered
2021-07-15
Start date
2021-07-15
Completion date
2025-05-31
Last updated
2026-05-08

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

Conditions

Acute Kidney Injury, Critical Illness

Keywords

Acute kidney injury, Biomarker, AKI progression, Poor outcome, Furosemide Stress Test

Brief summary

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

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.

Interventions

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

Sponsors

Guowei Tu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

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)

Design outcomes

Primary

MeasureTime frameDescription
AKI progression7 daysworsening of KDIGO stage within 1 week (progressing from stage 1 to either stage 2 or stage 3, or from stage 2 to stage 3). Patients diagnosed with progressive or persisting stage 3 AKI (stage 3 AKI for \>3 consecutive days) were classified as having AKI progression. If patients who presented with stage 3 AKI but not requiring RRT subsequently required dialysis or developing persist severe AKI or death within 7 days, this was considered progression.

Secondary

MeasureTime frameDescription
Mortality365 daysMortality at 30 days, 90 days and 365 days
Receipt of renal replacement treatment365 daysPatients received renal replacement treatment during hospital stay
Major adverse kidney events365 daysMAKE was defined as the composite of≥25% loss in estimated glomerular filtration rate (eGFR), dialysis, or death. Estimated GFR was calculated from serum creatinine using the MDRD equation
Persistent AKI90 daysPersistent AKI is characterized by the continuance of AKI by serum creatinine or urine output criteria (as defined by KDIGO) beyond 48h from AKI onset.
Persist severe AKI90 daysPersistent severe AKI was defined as follows: Patients with stage 3 AKI at enrollment required a persistence of 72 hours or more to meet the end point. Patients enrolled at stage 2 AKI required a progression to stage 3 within 48 hours and a persistence at stage 3 for 72 consecutive hours to be considered end point positive. Additionally, patients with severe AKI who failed to achieve 72 hours due to death or the initiation of RRT were considered end point positive.
Length of stay in the ICU90 daysLength of stay in the ICU
Length of stay in the hospital90 daysLength of stay in the hospital
AKI progression to stage 37 daysworsening of KDIGO stage to stage 3 within 1 week (progressing from stage 1 or stage 2 to stage 3).
AKI occurrence at 3 days3 daysAKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
AKI occurrence at 7 days7 daysAKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.

Countries

China

Contacts

STUDY_DIRECTORZhe Luo, Professor

Fudan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026