Acute Kidney InjuryNORDICANCT02263820
Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography
An observational study of Acute Kidney Injury and Renal Insufficiency, run by Sapere Bio at 1 site in United States.
Trial summary
Contrast-induced acute kidney injury (CI-AKI) has been recognized as the third most common cause of hospital acquired AKI, after hypotension-associated hypo-perfusion and post-operative AKI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Renal Insufficiency, Kidney Diseases
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2016
- 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: Adults undergoing cardiac catheterization with or without percutaneous coronary intervention (PCI)
Who may be able to join
- Adult patients (>18 yo) undergoing invasive coronary angiography with or without percutaneous coronary intervention (PCI), that are predicted to have ≥14% risk of developing AKI as defined by Mehran et al.
- Medically compliant and able to consent and follow detailed directions
- Agree to additional collection of blood sample 48-72h post cardiac catheterization
Who cannot join
- Presence of acute, active infection (e.g. HIV, pneumonia, septic shock).
- Contrast media exposure within last 48h
- Presenting with systolic time-segment elevation myocardial infarction.
- Presence of cardiogenic shock
- Presence of hemodynamic instability or requiring pressors or intra-aortic balloon pump
- Severe kidney disease with estimated glomerular filtration rate <30 mL/min/1.73m2 or receiving dialysis for end stage renal disease
Show all 11Show fewer
- Kidney transplant and liver transplant patients and all patients currently on immunosuppressants
- Severe heart failure with known ejection fraction <25%
- Prior heart transplant
- Chronic liver disease /cirrhosis
- Patients actively undergoing chemotherapy or radiation treatment for any indication.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center for Heart & Vascular Care
Chapel Hill, North Carolina, 27599
About this study
Official title: Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography (NORDICA Study)
Contrast-induced acute kidney injury (CI-AKI) has been recognized as the third most common cause of hospital acquired AKI, after hypotension-associated hypo-perfusion and post-operative AKI. The development of CI-AKI after cardiac catheterization is associated with a significant increase in both short-term and long-term mortality and morbidities, as well as an increase in length of stay and cost.
The only marker of renal function that has predictive ability is creatinine and it has significant limitations in identifying patients who will develop AKI. Therefore, a diagnostic test for predicting CI-AKI risk would have widespread clinical utility.
The primary purpose of this study is to measure the association between baseline expression of senescence markers in blood using SenesceTest and the occurrence of CI-AKI post cardiac catheterization.
- Conditions
- Acute Kidney Injury, Renal Insufficiency, Kidney Diseases
- Keywords
- Acute Kidney Injury, Acute Renal Failure
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum creatinine levels (absolute and percentage)
Measured: Measured 48-72h after catheterization
Secondary outcomes (2)
Major Adverse Clinical Events (MACE, a composite of all-cause mortality, myocardial infarction or renal replacement therapy)
Measured: Within 90 days after catheterization
Admission to the ICU
Measured: Within 90 days after catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sapere Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- George A Stouffer, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263820
- Sponsor's protocol ID
- HSDX-1502
- Acronym
- NORDICA
- Status last verified
- Aug 2018
- First submitted
- 8 Oct 2014
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography (NORDICA Study)
- ClinicalTrials.gov ID
- NCT02263820
- Acronym / sponsor ID
- NORDICA / HSDX-1502
- Conditions
- Acute Kidney Injury, Renal Insufficiency, Kidney Diseases
- Keywords
- Acute Kidney Injury, Acute Renal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Sapere BioIndustry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- Jan 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Oct 2014 (estimated)
- 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.
Contrast-induced acute kidney injury (CI-AKI) has been recognized as the third most common cause of hospital acquired AKI, after hypotension-associated hypo-perfusion and post-operative AKI. The development of CI-AKI after cardiac catheterization is associated with a significant increase in both short-term and long-term mortality and morbidities, as well as an increase in length of stay and cost.
The only marker of renal function that has predictive ability is creatinine and it has significant limitations in identifying patients who will develop AKI. Therefore, a diagnostic test for predicting CI-AKI risk would have widespread clinical utility.
The primary purpose of this study is to measure the association between baseline expression of senescence markers in blood using SenesceTest and the occurrence of CI-AKI post cardiac catheterization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing cardiac catheterization with or without percutaneous coronary intervention (PCI)
Key inclusion criteria (3 listed)
- Adult patients (>18 yo) undergoing invasive coronary angiography with or without percutaneous coronary intervention (PCI), that are predicted to have ≥14% risk of developing AKI as defined by Mehran et al.
- Medically compliant and able to consent and follow detailed directions
- Agree to additional collection of blood sample 48-72h post cardiac catheterization
Key exclusion criteria (11 listed)
- Presence of acute, active infection (e.g. HIV, pneumonia, septic shock).
- Contrast media exposure within last 48h
- Presenting with systolic time-segment elevation myocardial infarction.
- Presence of cardiogenic shock
- Presence of hemodynamic instability or requiring pressors or intra-aortic balloon pump
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
Changes in serum creatinine levels (absolute and percentage)
Time frame: Measured 48-72h after catheterization
2 secondary outcomes
Major Adverse Clinical Events (MACE, a composite of all-cause mortality, myocardial infarction or renal replacement therapy)
Time frame: Within 90 days after catheterization
Admission to the ICU
Time frame: Within 90 days after catheterization
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 17 Aug 2018.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
George A Stouffer, MD principal investigator
University of North Carolina
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 and Renal Insufficiency, run by Sapere Bio at 1 site in United States.
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 3 inclusion and 11 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 17 Aug 2018. 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 United States. 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?
Changes in serum creatinine levels (absolute and percentage) (time frame: Measured 48-72h after catheterization). 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 17 Aug 2018.