Skip to main content
OpenTrials
Completed

NCT Number: NCT03854825

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac surgery

Procedure

Primary outcomes

  1. NEP-levels

    Time frame: 24 hours

    Difference of NEP-levels after cardiac surgery on the first postoperative day

Secondary outcomes

  1. NEP-levels

    Time frame: approximately 6 hours

    Difference of NEP-levels after cardiac surgery at the end of procedure

  2. Increase of NEP

    Time frame: approximately 6 hours

    Time-dependent increase of NEP during CPB

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Acronym: NEPAKI-CS

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Feb 26, 2019
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.