Acute Kidney Injury (Nontraumatic)AKIriskNCT03830450
Biomarkers of Acute Kidney Injury in Cardiac Surgery
An observational study of Acute Kidney Injury (Nontraumatic), run by Nikola Bradic, MD.
Trial summary
Acute kidney injury (AKI) is the most common complication in patients after cardiac surgery. An usual estimation of risk for AKI is estimation of serum creatinine, which is unreliable indicator of AKI risk. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury (Nontraumatic)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 31 Dec 2022
- How long will I take part?
- 1 Year
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for cardiac surgery with usage of cardiopulmonary bypass
Who may be able to join
- patients scheduled for cardiac surgery (CABG, valve replacement/repair, combined)
- older than 18 years
Who cannot join
- previous known renal disease
- patients on chronic dialysis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Biomarkers in Estimation for Risk of Acute Kidney Injury in Cardiac Surgery
Acute kidney injury (AKI) is the most common complication in patients after cardiac surgery. An usual estimation of risk for AKI is estimation of serum creatinine, which is unreliable indicator of AKI risk. Because of that, today different biomarkers are investigated to predict incidence for development AKI after cardiac surgery. This investigation will try to find potentially risk patients for developing AKI after cardiac surgery by using conventional markers (creatinine, glomerular filtration rate) in perioperative period comparing with two different biomarkers neutrophil gelatinase-associated lipocalin (NGAL) and growth differentiation factor 15 (GDF-15) which are proven markers in patients with increased risk for AKI development.
- Conditions
- Acute Kidney Injury (Nontraumatic)
- Keywords
- Acute kidney injury, Cardiac surgery, NGAL, GDF-15
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Consecutive values of neutrophil gelatinase-associated lipocalin (NGAL)
By the changing of NGAL values in consecutive measuring, predict which patients are in increased risk for development of AKI
Measured: One year
Consecutive values of growth differentiation factor 15 (GDF-15)
By the changing of GDF-15 values in consecutive measuring, predict which patients are in increased risk for development of AKI
Measured: One year
Consecutive values of glomerular filtration rate (GFR)
By the changing of GFR values in consecutive measuring, predict which patients are in increased risk for development of AKI
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Dec 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury (Nontraumatic)Studies of the same condition, open and under way.
- 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
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Nikola Bradic, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nikola Bradic, MD, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830450
- Sponsor's protocol ID
- University North
- Acronym
- AKIrisk
- Status last verified
- Nov 2020
- First submitted
- 2 Feb 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Estimation for Risk of Acute Kidney Injury in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03830450
- Acronym / sponsor ID
- AKIrisk / University North
- Conditions
- Acute Kidney Injury (Nontraumatic)
- Keywords
- Acute kidney injury, Cardiac surgery, NGAL, GDF-15
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nikola Bradic, MDUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 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.
Acute kidney injury (AKI) is the most common complication in patients after cardiac surgery. An usual estimation of risk for AKI is estimation of serum creatinine, which is unreliable indicator of AKI risk. Because of that, today different biomarkers are investigated to predict incidence for development AKI after cardiac surgery. This investigation will try to find potentially risk patients for developing AKI after cardiac surgery by using conventional markers (creatinine, glomerular filtration rate) in perioperative period comparing with two different biomarkers neutrophil gelatinase-associated lipocalin (NGAL) and growth differentiation factor 15 (GDF-15) which are proven markers in patients with increased risk for AKI development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for cardiac surgery with usage of cardiopulmonary bypass
Key inclusion criteria (2 listed)
- patients scheduled for cardiac surgery (CABG, valve replacement/repair, combined)
- older than 18 years
Key exclusion criteria (2 listed)
- previous known renal disease
- patients on chronic dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Consecutive values of neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: One year
By the changing of NGAL values in consecutive measuring, predict which patients are in increased risk for development of AKI
Consecutive values of growth differentiation factor 15 (GDF-15)
Time frame: One year
By the changing of GDF-15 values in consecutive measuring, predict which patients are in increased risk for development of AKI
Consecutive values of glomerular filtration rate (GFR)
Time frame: One Year
By the changing of GFR values in consecutive measuring, predict which patients are in increased risk for development of AKI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
Related trials for Acute Kidney Injury (Nontraumatic)
Active, not recruiting
Effect of an Intervention to Prevent Acute Kidney Injury Versus Standard Care in High-risk Patients After Major Surgery
Acute Kidney Injury (Nontraumatic)
Recruiting
WISDOM UK: Low Dose-intensity Versus Standard Dose-intensity CRRT in Critically Ill Patients
Acute Kidney Injury (Nontraumatic), Dialysis; Complications
RecruitingObservational study
AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia
Acute Kidney Injury (Nontraumatic), Hypotension Drug-Induced
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury (Nontraumatic), run by Nikola Bradic, MD.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikola Bradic, MD (+385 91 589 3480, nbradic@kbd.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consecutive values of neutrophil gelatinase-associated lipocalin (NGAL) (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2020.