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

April 19, 2019 updated by: Dr. Martin Bernardi, Medical University of Vienna
The investigators want to investigate if the urinary biomarker neprilysin can identify cardiac surgical patients suffering from postoperative AKI within 24 hours.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elective cardiac surgical patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AKI
patients with postoperative AKI defined by KDIGO
Procedure: Cardiac surgery
no AKI
patients without postoperative AKI defined by KDIGO
Procedure: Cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NEP-levels
Time Frame: 24 hours
Difference of NEP-levels after cardiac surgery on the first postoperative day
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NEP-levels
Time Frame: approximately 6 hours
Difference of NEP-levels after cardiac surgery at the end of procedure
approximately 6 hours
Increase of NEP
Time Frame: approximately 6 hours
Time-dependent increase of NEP during CPB
approximately 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2016

Primary Completion (Actual)

January 25, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

February 24, 2019

First Submitted That Met QC Criteria

February 24, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2019

Last Update Submitted That Met QC Criteria

April 19, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1223/2015_1.9

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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