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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06351813
Enrollment
358
Registered
2024-04-08
Start date
2024-07-01
Completion date
2027-12-31
Last updated
2024-06-10

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, Kidney Failure

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frameDescription
AKI nonresolving subphenotype7 daysThe 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

MeasureTime frameDescription
Major adverse kidney events at 90 days90 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.
Major adverse kidney events at 365 days365 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 modification of diet in renal disease (MDRD) equation.
Mortality365 daysMortality at 30 days, 90 days and 365 days
Major adverse kidney events at 30 days30 daysMajor 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.
Moderate and severe AKI7 daysKidney Disease Improving Global Outcomes (KDIGO) stage 2 or stage 3
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.
Composite Outcome30 daysStage 3 AKI, renal replacement therapy or death through outpatient or telephone follow-up
Receipt of renal replacement treatment365 daysPatients received renal replacement treatment during hospital stay

Countries

China

Contacts

Primary ContactYing Su, Dr.
su.ying@zs-hospital.sh.cn+86-021-64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026