Clinical trial NCT03854825: Neutral Endopeptidase for Early Detection of Acute Kidney Injury After Cardiac Surgery
Official title: Neutral Endopeptidase for Early Detection of Acute Kidney Injury After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective cardiac surgical patients

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: NEP-levels
timeFrame: 24 hours
Secondary outcomes:
measure: NEP-levels
timeFrame: approximately 6 hours
measure: Increase of NEP
timeFrame: approximately 6 hours
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna
Study officials:
References:
citation: Bernardi MH, Wagner L, Ryz S, Puchinger J, Nixdorf L, Edlinger-Stanger M, Geilen J, Kainz M, Hiesmayr MJ, Lassnigg A. Urinary neprilysin for early detection of acute kidney injury after cardiac surgery: A prospective observational study. Eur J Anaesthesiol. 2021 Jan;38(1):13-21. doi: 10.1097/EJA.0000000000001321.