Clinical trial NCT04962412: Predicting Poor Outcomes of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers
Official title: Predicting Poor Outcomes of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Critical Illness
Keywords: Acute kidney injury
Biomarker
AKI progression
Poor outcome
Furosemide Stress Test
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 5010
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: AKI progression
timeFrame: 7 days
Secondary outcomes:
measure: Mortality
timeFrame: 365 days
measure: Receipt of renal replacement treatment
timeFrame: 365 days
measure: Major adverse kidney events
timeFrame: 365 days
measure: Persistent AKI
timeFrame: 90 days
measure: Persist severe AKI
timeFrame: 90 days
measure: Length of stay in the ICU
timeFrame: 90 days
measure: Length of stay in the hospital
timeFrame: 90 days
measure: AKI progression to stage 3
timeFrame: 7 days
measure: AKI occurrence at 3 days
timeFrame: 3 days
measure: AKI occurrence at 7 days
timeFrame: 7 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital, Fudan university
Study officials:
affiliation: Fudan University
name: Zhe Luo, Professor
role: STUDY_DIRECTOR
References: