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

Sponsor

Guowei Tu (Other)

Overall Status

Recruiting

CT.gov ID

NCT04962412

Collaborator

(none)

5,010

Enrollment

Location

55.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Critical Illness	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5010 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 12, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

AKI progression [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 Outcome Measures

Mortality [90 days]
Mortality at 30 days and 90 days
Receipt of renal replacement treatment [90 days]
Patients received renal replacement treatment during hospital stay
Major adverse kidney events [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
Persistent AKI [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.
Persist severe AKI [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.
Length of stay in the ICU [90 days]
Length of stay in the ICU
Length of stay in the hospital [90 days]
Length of stay in the hospital
AKI progression to stage 3 [7 days]
worsening of KDIGO stage to stage 3 within 1 week (progressing from stage 1 or stage 2 to stage 3).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

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)