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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06351813
• Other study ID #: B2024-029R
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2024
• Source: Shanghai Zhongshan Hospital
• Contact: Ying Su, Dr.
• Phone: +86-021-64041990
• Email: su.ying[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 358
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Kidney Failure
• Renal Insufficiency
• Wounds and Injuries

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (3)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AKI nonresolving subphenotype	The 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	7 days
Secondary	Major adverse kidney events at 30 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.	30 days
Secondary	Major adverse kidney events at 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.	90 days
Secondary	Major adverse kidney events at 365 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 modification of diet in renal disease (MDRD) equation.	365 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	Moderate and severe AKI	Kidney Disease Improving Global Outcomes (KDIGO) stage 2 or stage 3	7 days
Secondary	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	Composite Outcome	Stage 3 AKI, renal replacement therapy or death through outpatient or telephone follow-up	30 days