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NCT Number: NCT06351813

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

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.

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Key information

About this study

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.

Who can participate

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

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)

Treatment and study plan

Primary outcomes

  1. AKI nonresolving subphenotype

    Time frame: 7 days

    The resolving subphenotype was defined by a decrease of 0.3 mg/dl or 25% in SCr from its maximum during the first 3 days of study enrollment. All subjects with AKI who did not meet this criterion were classified as having a nonresolving subphenotype

Secondary outcomes

  1. Major adverse kidney events at 30 days

    Time frame: 30 days

    Major adverse kidney events (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.

  2. Major adverse kidney events at 90 days

    Time frame: 90 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.

  3. Major adverse kidney events at 365 days

    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 modification of diet in renal disease (MDRD) equation.

  4. Mortality

    Time frame: 365 days

    Mortality at 30 days, 90 days and 365 days

  5. Receipt of renal replacement treatment

    Time frame: 365 days

    Patients received renal replacement treatment during hospital stay

  6. Moderate and severe AKI

    Time frame: 7 days

    Kidney Disease Improving Global Outcomes (KDIGO) stage 2 or stage 3

  7. 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.

  8. Composite Outcome

    Time frame: 30 days

    Stage 3 AKI, renal replacement therapy or death through outpatient or telephone follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Su, Dr.

CONTACT

[email protected]

+86-021-64041990

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
  • Zhongshan Hospital (Xiamen), Fudan University

Registry information

Official study title

Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers--A Multicenter Observational Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 8, 2024
Registry last updated
Jun 10, 2024

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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