Acute Kidney InjuryNEPAKI-CSNCT03854825
Neutral Endopeptidase for Early Detection of Acute Kidney Injury After Cardiac Surgery
An observational study of Acute Kidney Injury, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The investigators want to investigate if the urinary biomarker neprilysin can identify cardiac surgical patients suffering from postoperative AKI within 24 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 30 Oct 2016to 1 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective cardiac surgical patients
Who may be able to join
- Patients undergoing an elective cardiac surgical intervention
Who cannot join
- Emergency procedures
- Heart transplantation
- Elective left ventricular assist device (LVAD) implantation
- Pulmonary thrombendarterectomy
- Declined informed consent
- Age < 18 years
Show all 9Show fewer
- Pregnant woman
- Preoperative renal replacement therapy (RRT)
- Receiving medication containing sacubitril
Trial locations and contacts
1 site in 1 country.
Austria1 site
Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna
Vienna, 1090
About this study
The investigators want to investigate if the urinary biomarker neprilysin can identify cardiac surgical patients suffering from postoperative AKI within 24 hours.
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- Cardiac surgery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| AKI | patients with postoperative AKI defined by KDIGO Receives: Procedure: Cardiac surgery | |
| no AKI | patients without postoperative AKI defined by KDIGO Receives: Procedure: Cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEP-levels
Difference of NEP-levels after cardiac surgery on the first postoperative day
Measured: 24 hours
Secondary outcomes (2)
NEP-levels
Difference of NEP-levels after cardiac surgery at the end of procedure
Measured: approximately 6 hours
Increase of NEP
Time-dependent increase of NEP during CPB
Measured: approximately 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start30 Oct 2016
- Primary completion25 Jan 2018
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Martin Bernardi, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854825
- Sponsor's protocol ID
- 1223/2015_1.9
- Acronym
- NEPAKI-CS
- Status last verified
- Apr 2019
- First submitted
- 24 Feb 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32941200
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutral Endopeptidase for Early Detection of Acute Kidney Injury After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03854825
- Acronym / sponsor ID
- NEPAKI-CS / 1223/2015_1.9
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 30 Oct 2016 (actual)
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI | – | Procedure: Cardiac surgerypatients with postoperative AKI defined by KDIGO |
| no AKI | – | Procedure: Cardiac surgerypatients without postoperative AKI defined by KDIGO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective cardiac surgical patients
Key inclusion criteria (1 listed)
- Patients undergoing an elective cardiac surgical intervention
Key exclusion criteria (9 listed)
- Emergency procedures
- Heart transplantation
- Elective left ventricular assist device (LVAD) implantation
- Pulmonary thrombendarterectomy
- Declined informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgery | Procedure or surgery | AKI, no AKI |
Primary outcome
NEP-levels
Time frame: 24 hours
Difference of NEP-levels after cardiac surgery on the first postoperative day
2 secondary outcomes
NEP-levels
Time frame: approximately 6 hours
Increase of NEP
Time frame: approximately 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Derived from this study: PubMed 32941200Bernardi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NEP-levels (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03854825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.