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Neutral Endopeptidase for Early Detection of Acute Kidney Injury After Cardiac Surgery

Neutral Endopeptidase for Early Detection of Acute Kidney Injury After Cardiac Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03854825
Acronym
NEPAKI-CS
Enrollment
100
Registered
2019-02-26
Start date
2016-10-30
Completion date
2019-04-01
Last updated
2019-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

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.

Interventions

PROCEDURECardiac surgery

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
NEP-levels24 hoursDifference of NEP-levels after cardiac surgery on the first postoperative day

Secondary

MeasureTime frameDescription
NEP-levelsapproximately 6 hoursDifference of NEP-levels after cardiac surgery at the end of procedure
Increase of NEPapproximately 6 hoursTime-dependent increase of NEP during CPB

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026