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Completed

NCT Number: NCT04962412

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

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

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Key information

Conditions

Acute Kidney Injury Critical Illness Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan hospital, Fudan university

Shanghai, 200030, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard care "bundle"

Other

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

Primary outcomes

  1. AKI progression

    Time frame: 7 days

    worsening 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 outcomes

  1. Mortality

    Time frame: 365 days

    Mortality at 30 days, 90 days and 365 days

  2. Receipt of renal replacement treatment

    Time frame: 365 days

    Patients received renal replacement treatment during hospital stay

  3. Major adverse kidney events

    Time frame: 365 days

    MAKE 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

  4. Persistent AKI

    Time frame: 90 days

    Persistent AKI is characterized by the continuance of AKI by serum creatinine or urine output criteria (as defined by KDIGO) beyond 48h from AKI onset.

  5. Persist severe AKI

    Time frame: 90 days

    Persistent 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.

  6. Length of stay in the ICU

    Time frame: 90 days

    Length of stay in the ICU

  7. Length of stay in the hospital

    Time frame: 90 days

    Length of stay in the hospital

  8. AKI progression to stage 3

    Time frame: 7 days

    worsening of KDIGO stage to stage 3 within 1 week (progressing from stage 1 or stage 2 to stage 3).

  9. AKI occurrence at 3 days

    Time frame: 3 days

    AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.

  10. AKI occurrence at 7 days

    Time frame: 7 days

    AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.

Sponsors and collaborators

Lead sponsor

Guowei Tu

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jul 15, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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