NCT03854825

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

February 24, 2019

Last Update Submit

April 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • NEP-levels

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

    24 hours

Secondary Outcomes (2)

  • NEP-levels

    approximately 6 hours

  • Increase of NEP

    approximately 6 hours

Study Arms (2)

AKI

patients with postoperative AKI defined by KDIGO

Procedure: Cardiac surgery

no AKI

patients without postoperative AKI defined by KDIGO

Procedure: Cardiac surgery

Interventions

AKIno AKI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elective cardiac surgical patients

You may qualify if:

  • \- Patients undergoing an elective cardiac surgical intervention

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neutral Endopeptidase for early detection of acute kidney injury after cardiac surgery

Study Record Dates

First Submitted

February 24, 2019

First Posted

February 26, 2019

Study Start

October 30, 2016

Primary Completion

January 25, 2018

Study Completion

April 1, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations