Neutral Endopeptidase for Early Detection of Acute Kidney... | NCT03854825

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

NCT03854825

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Apr 22, 2019Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

Cardiac surgery

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2016Actual

Primary Completion Date

Jan 25, 2018Actual

Completion Date

Apr 1, 2019Actual

First Submitted Date

Feb 24, 2019

First Submission Date that Met QC Criteria

Feb 24, 2019

First Posted Date

Feb 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2019

Last Update Posted Date

Apr 22, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Martin Bernardi, Neutral Endopeptidase for early detection of acute kidney injury after cardiac surgery, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AKI		patients with postoperative AKI defined by KDIGO	Procedure: Cardiac surgery
no AKI		patients without postoperative AKI defined by KDIGO	Procedure: Cardiac surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac surgery	Procedure		AKI no AKI

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Elective cardiac surgical patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna		Vienna		1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32941200	Derived	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.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures