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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04962412
• Other study ID #: B2021-390R
• Status: Recruiting
• Start date: May 12, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Shanghai Zhongshan Hospital
• Contact: Guo-wei Tu, MD
• Phone: 86-021-64041990
• Email: tu.guowei[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5010
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients undergoing cardiac surgery were prospectively enrolled.

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan hospital, Fudan university	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Guowei Tu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Mortality at 30 days, 90 days and 365 days	365 days
Secondary	Receipt of renal replacement treatment	Patients received renal replacement treatment during hospital stay	365 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of stay in the ICU	Length of stay in the ICU	90 days
Secondary	Length of stay in the hospital	Length of stay in the hospital	90 days
Secondary	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
Secondary	AKI occurrence at 3 days	AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.	3 days
Secondary	AKI occurrence at 7 days	AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.	7 days