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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Acute Kidney Injury
• Intervention / Treatment: Other: Standard care "bundle"

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.

• Study Type: Observational
• Enrollment (Actual): 3152

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200030
    • Zhongshan hospital, Fudan university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42%. CSA-AKI is the second most common cause of AKI in the intensive care setting (after sepsis) and is independently associated with increased morbidity and mortality. Patients was diagnosed AKI by KDIGO criteria.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AKI progression	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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistent AKI	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.	90 days
Persist severe AKI	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.	90 days
Length of stay in the ICU	Length of stay in the ICU	90 days
Length of stay in the hospital	Length of stay in the hospital	90 days
AKI progression to stage 3	worsening of KDIGO stage to stage 3 within 1 week (progressing from stage 1 or stage 2 to stage 3).	7 days
Mortality	Mortality at 30 days, 90 days and 365 days	365 days
Receipt of renal replacement treatment	Patients received renal replacement treatment during hospital stay	365 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	365 days
AKI occurrence at 3 days	AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.	3 days
AKI occurrence at 7 days	AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.	7 days

Collaborators and Investigators

• Sponsor: Guowei Tu
• Investigators: Study Director: Zhe Luo, Professor, Fudan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Biomarker; Acute kidney injury; Furosemide Stress Test; Poor outcome; AKI progression
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Critical Illness; Acute Kidney Injury
• Other Study ID Numbers: B2021-390R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No