ErythropoietinEPONCT01393418
Evaluating Erythropoietin as an Indicator for Possible Kidney Injury After Cardiac Surgery
An observational study of Erythropoietin and Acute Kidney Injury, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of the study is to evaluate kidney biomarkers and determine if there is a correlation between Erythropoietin (EPO) levels and acute kidney injury after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythropoietin, Acute Kidney Injury, Renal Biomarker
- What is being tested?
- Cardiac Surgery
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Mar 2012
- 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: Cardiac surgery patients.
Who may be able to join
- Cardiac surgery with cardiopulmonary bypass with DHCA
- Normal renal function or renal insufficiency-serum creatinine less than 2.5 mg/dL
- Adult male and female patients 18 years and older
Who cannot join
- VADS
- Emergent cases
- Prolonged hypoxemia before, during or after bypass
- End stage renal disease
- Patients receive erythropoietin receptor agonists
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: EPO: A Renal Biomarker After Cardiac Surgery
The purpose of the study is to evaluate kidney biomarkers and determine if there is a correlation between Erythropoietin (EPO) levels and acute kidney injury after cardiac surgery. An early biomarker for kidney injury may be helpful in identifying, monitoring and managing patients at risk for kidney failure after cardiac surgery. To evaluate Erythropoietin's role as a predictor of poor renal function in the immediate post-bypass period we plan to compare EPO levels to Neutrophil gelatinase-associated lipocalin (NGAL).
Read the detailed description
Acute kidney injury (AKI) is a serious complication after cardiac surgery and cardio-pulmonary bypass. AKI is associated with high mortality.
Erythropoietin, a hormone produced by the kidneys, will be evaluated as a potential biomarker of kidney injury. Neutrophil gelatinase-associated lipocalin (NGAL) has been studied as a biomarker of kidney injury. Early kidney injury detection has been long sought and NGAL has been shown to be a promising biomarker. A troponinlike biomarker of AKI that is easily measured and capable of both early detection and risk stratification would represent an advancement in our ability to differentiate acute kidney injury from failure.
Investigating EPO as a biomarker may prove to have increased predictive value in the clinical care of cardiac surgery patients.
- Conditions
- Erythropoietin, Acute Kidney Injury, Renal Biomarker
- Being tested
- Cardiac Surgery
- Keywords
- Erythropoietin, Cardiac Surgery, Renal Biomarker, Acute Kidney Injury, Hypothermic Circulatory Arrest
- 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 SurgeryOther
| Study group | Role | What they receive |
|---|---|---|
| Subjects undergoing cardiac surgery | Not described Receives: Other: Cardiac Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal injury/Failure
Measured: 18 Hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startNov 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythropoietinStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Kouatli, University of Michigan
- Investigators
- Yasser El Kouatli, MD, Principal investigator, Department of Anesthesiology, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393418
- Sponsor's protocol ID
- HUM41529
- Acronym
- EPO
- Status last verified
- Dec 2016
- First submitted
- 12 Jul 2011
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPO: A Renal Biomarker After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01393418
- Acronym / sponsor ID
- EPO / HUM41529
- Conditions
- Erythropoietin, Acute Kidney Injury, Renal Biomarker
- Keywords
- Erythropoietin, Cardiac Surgery, Renal Biomarker, Acute Kidney Injury, Hypothermic Circulatory Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Jul 2011 (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.
The purpose of the study is to evaluate kidney biomarkers and determine if there is a correlation between Erythropoietin (EPO) levels and acute kidney injury after cardiac surgery. An early biomarker for kidney injury may be helpful in identifying, monitoring and managing patients at risk for kidney failure after cardiac surgery. To evaluate Erythropoietin's role as a predictor of poor renal function in the immediate post-bypass period we plan to compare EPO levels to Neutrophil gelatinase-associated lipocalin (NGAL).
Detailed description
Acute kidney injury (AKI) is a serious complication after cardiac surgery and cardio-pulmonary bypass. AKI is associated with high mortality.
Erythropoietin, a hormone produced by the kidneys, will be evaluated as a potential biomarker of kidney injury. Neutrophil gelatinase-associated lipocalin (NGAL) has been studied as a biomarker of kidney injury. Early kidney injury detection has been long sought and NGAL has been shown to be a promising biomarker. A troponinlike biomarker of AKI that is easily measured and capable of both early detection and risk stratification would represent an advancement in our ability to differentiate acute kidney injury from failure.
Investigating EPO as a biomarker may prove to have increased predictive value in the clinical care of cardiac surgery patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects undergoing cardiac surgery | – | Other: Cardiac Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac surgery patients.
Key inclusion criteria (3 listed)
- Cardiac surgery with cardiopulmonary bypass with DHCA
- Normal renal function or renal insufficiency-serum creatinine less than 2.5 mg/dL
- Adult male and female patients 18 years and older
Key exclusion criteria (5 listed)
- VADS
- Emergent cases
- Prolonged hypoxemia before, during or after bypass
- End stage renal disease
- Patients receive erythropoietin receptor agonists
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 | Other | Subjects undergoing cardiac surgery |
Primary outcome
Renal injury/Failure
Time frame: 18 Hours after surgery
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 15 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Erythropoietin
RecruitingPhase 3
A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Lower Risk Myelodysplastic Syndromes (LR-MDS) Who Need Regular Blood Transfusions
Myelodysplastic Syndrome, Anemia
Not yet recruitingPhase 2
HEC53856 Tablets for Chemotherapy-induced Anemia in Non-myeloid Malignancies
Chemotherapy-induced Anemia, Non-Myeloid Malignancy
Not yet recruitingObservational study
ESA Hyporesponsiveness in Hemodialysis Patients
Chronic Kidney Disease (CKD), Hemodialysis Complication
Active, not recruiting
The Effects of Acute Erythropoietin on Hepcidin and Dietary Iron Absorption Following Military-relevant Exercise in Energy Deficit: Pilot Study
Iron Absorption
RecruitingPhase 2
Combination Therapy of Romiplostim and Erythropoiesis-stimulating Agents
Anemia Associated With Chronic Kidney Disease
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.
Yasser El Kouatli, MD principal investigator
Department of Anesthesiology, University of Michigan
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 Erythropoietin and Acute Kidney Injury, run by University of Michigan 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 5 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 15 Dec 2016. 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?
Renal injury/Failure (time frame: 18 Hours after surgery). 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 15 Dec 2016.