Neutral Endopeptidase for Early Detection of Acute Kidney Injury After Cardiac Surgery (NEPAKI-CS)

Medical University of Vienna

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Procedure: Cardiac surgery

Study type: Observational

Funder types: Other

Identifiers

NCT03854825

1223/2015_1.9

Details and patient eligibility

About

The investigators want to investigate if the urinary biomarker neprilysin can identify cardiac surgical patients suffering from postoperative AKI within 24 hours.

Full description

Acute kidney injury (AKI) is a common complication following cardiac surgery and significantly increases morbidity, duration of hospital stay, and mortality. The diagnosis of AKI relies on changes in serum creatinine (SCr) from a baseline value or decreases in urine output. Nevertheless changes of SCr to diagnose AKI are only reliable after a minimum of 48 hours.

Neutral endopeptidase, also called neprilysin (NEP) represents a single-pass membrane glycoprotein with zinc-dependent endopeptidase activity and a short cytosolic tail and is found in epithelia, fibroblasts, and neutrophils and in soluble form in the circulation, urine, and cerebrospinal fluid. Beside the focus of interest in cardiovascular medicine for its role in heart failure, where the inhibition of NEP by the administration of sacubitril/valsartan may achieve an improvement in patients with chronic heart failure and reduced ejection fraction, there is also thought to be a link to renal damage.

NEP is expressed in the brush border of proximal tubular cells, which is first shed in renal damage and therefore it is a marker for tubular damage when it is measurable in urine In this study the investigators want to investigate if NEP is a marker for earlier detection of AKI after elective cardiac surgery compared to the currently recommended Kidney Disease - Improved Global Outcomes (KDIGO) guidelines for acute kidney injury. Also, the investigators want to investigate at predefined time points the occurrence and the progression of tubular damage during cardio-pulmonary bypass (CPB) in a closed-meshed NEP detection.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing an elective cardiac surgical intervention

Exclusion criteria

• Emergency procedures
• Heart transplantation
• Elective left ventricular assist device (LVAD) implantation
• Pulmonary thrombendarterectomy
• Declined informed consent
• Age < 18 years
• Pregnant woman
• Preoperative renal replacement therapy (RRT)
• Receiving medication containing sacubitril

Trial design

100 participants in 2 patient groups

AKI

Description:

patients with postoperative AKI defined by KDIGO

Treatment:

Procedure: Cardiac surgery

no AKI

Description:

patients without postoperative AKI defined by KDIGO

Treatment:

Procedure: Cardiac surgery