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

Completed

• Conditions: Acute Kidney Injury
• Interventions: Procedure: Cardiac surgery

• Registration Number: NCT03854825
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2016-10-30
• Primary Completion: 2018-01-25
• Study First Submitted: 2019-02-24
• Study First Submitted QC: 2019-02-24
• Study First Posted: 2019-02-26
• Status Verified: 2019-04
• Study Completion: 2019-04-01
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients undergoing an elective cardiac surgical intervention

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AKI	Cardiac surgery	patients with postoperative AKI defined by KDIGO
no AKI	Cardiac surgery	patients without postoperative AKI defined by KDIGO

Primary Outcome Measures

Name	Time	Method
NEP-levels	24 hours	Difference of NEP-levels after cardiac surgery on the first postoperative day

Secondary Outcome Measures

Name	Time	Method
Increase of NEP	approximately 6 hours	Time-dependent increase of NEP during CPB
NEP-levels	approximately 6 hours	Difference of NEP-levels after cardiac surgery at the end of procedure

Trial Locations

Locations (1)

Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna; 🇦🇹 Vienna, Austria