Acute Kidney InjuryNCT01918046
MIOX for Early Detection of Acute Kidney Injury After Cardiac Surgery
An observational study of Acute Kidney Injury, run by Barnes-Jewish Hospital at 1 site in United States.
Trial summary
This is a single-center, prospective sample collection study. Samples will be used to establish the performance characteristics of myo-inositol oxygenase (MIOX) as an aid in the early diagnosis of acute renal injury (AKI) following cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 2014
- 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: Patients undergoing cardiac surgery at BJH
Who may be able to join
- Male or female scheduled for cardiac surgery including placement of Left or Right ventricular assist devices, requiring cardiopulmonary bypass
- Age greater than or equal to 18 years
Who cannot join
- Age less than 18 years
- Inability to obtain Informed Consent from patient or representative
- Prisoners or other institutionalized or vulnerable individuals.
- Participation in an interventional clinical study within the previous 30 days.
- History of previous renal transplantation
- Stage 4 or 5 chronic kidney disease (estimated GFR< 30 mL/min/1.73m2)
Show all 12Show fewer
- Known or suspected ongoing pre-operative acute renal failure due to any cause, including pre-renal, intrinsic renal or post-renal (obstructive) etiologies (as evidenced by increasing serum creatinine or oliguria pre-operatively)
- Already receiving dialysis, in imminent need of dialysis or considered highly likely to need dialysis in the immediate post-operative period for fluid management.
- Any known or suspected renal ischemic or nephrotoxic insult (such as cardiac arrest, intravenous contrast procedure, etc) during the 48 hrs prior to surgery.
- Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) infection; hepatitis B virus (HBV) infection or other infectious hepatitis.
- Pre-operative hematocrit < 25%, recent blood transfusions have been administered to maintain hematocrit > 25% or any other contraindication to obtaining the study specified blood samples.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Anitha Vijayan, MD, avijayan@dom.wustl.edu
Joseph Gaut, MD,PhD
About this study
This is a single-center, prospective sample collection study. Samples will be used to establish the performance characteristics of myo-inositol oxygenase (MIOX) as an aid in the early diagnosis of acute renal injury (AKI) following cardiac surgery.
Read the detailed description
Approximately 100 adults scheduled to undergo cardiac surgery involving the use of cardiopulmonary bypass will be eligible for enrollment in this study. Blood and urine samples will be obtained from all patients in the study for future measurement of both MIOX and creatinine concentrations in the same sample at each of the following time points:
- Baseline (within 24 hours prior to the start of surgery)
- Immediately following cardiopulmonary bypass (time 0), 3 (± 1), 6 (± 2), 12 (+/-2) 18 (± 2), and 24 (± 2) hours following cardiopulmonary bypass.
Urine and lithium heparin anti-coagulated blood will be collected at each time point. Blood and urine samples will be immediately centrifuged, aliquoted, and frozen at -80oC prior to analysis. Samples will be stored and analyzed at Washington University School of Medicine.
The results of these assessments will be blinded to the medical team during the study and will not impact the medical management of the patient.
Serum creatinine measurements obtained by the medical team as part of routine care both pre-operatively and post-operatively as well as any additional post-operative renal insults, the development of oliguria, need for a nephrology consultation, length of intensive care unit (ICU) stay, initiation of dialysis and mortality will be recorded through Day 10. Patients will be followed throughout their hospital stay, which on average is expected to be about 10 days.
The statistical analysis will evaluate the correlation of plasma and urine MIOX (absolute and change from baseline) with parameters indicative of renal injury (e.g., increases in plasma creatinine through Day 5 and development of oliguria, need for a nephrology consult or initiation of dialysis through Day 10). These results will assist in establishing the sensitivity and specificity of plasma and urine MIOX for the detection of meaningful kidney injury following cardiopulmonary bypass surgery.
- Conditions
- Acute Kidney Injury
- Keywords
- biomarker, MIOX
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
Measured: 10 days
Secondary outcomes (1)
Renal replacement therapy
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014 (estimated)
- Study completionSep 2014 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barnes-Jewish Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anitha Vijayan, MD, Washington University School of Medicine
- Investigators
- Joseph Gaut, MD, PhD, Principal investigator, Washington University School of MedicineAnitha Vijayan, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918046
- Sponsor's protocol ID
- MIOX-1
- Status last verified
- Aug 2013
- First submitted
- 30 Jul 2013
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIOX for Early Detection of Acute Kidney Injury After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01918046
- Acronym / sponsor ID
- MIOX-1
- Conditions
- Acute Kidney Injury
- Keywords
- biomarker, MIOX
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Barnes-Jewish HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 7 Aug 2013 (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.
This is a single-center, prospective sample collection study. Samples will be used to establish the performance characteristics of myo-inositol oxygenase (MIOX) as an aid in the early diagnosis of acute renal injury (AKI) following cardiac surgery.
Detailed description
Approximately 100 adults scheduled to undergo cardiac surgery involving the use of cardiopulmonary bypass will be eligible for enrollment in this study. Blood and urine samples will be obtained from all patients in the study for future measurement of both MIOX and creatinine concentrations in the same sample at each of the following time points:
- Baseline (within 24 hours prior to the start of surgery)
- Immediately following cardiopulmonary bypass (time 0), 3 (± 1), 6 (± 2), 12 (+/-2) 18 (± 2), and 24 (± 2) hours following cardiopulmonary bypass.
Urine and lithium heparin anti-coagulated blood will be collected at each time point. Blood and urine samples will be immediately centrifuged, aliquoted, and frozen at -80oC prior to analysis. Samples will be stored and analyzed at Washington University School of Medicine.
The results of these assessments will be blinded to the medical team during the study and will not impact the medical management of the patient.
Serum creatinine measurements obtained by the medical team as part of routine care both pre-operatively and post-operatively as well as any additional post-operative renal insults, the development of oliguria, need for a nephrology consultation, length of intensive care unit (ICU) stay, initiation of dialysis and mortality will be recorded through Day 10. Patients will be followed throughout their hospital stay, which on average is expected to be about 10 days.
The statistical analysis will evaluate the correlation of plasma and urine MIOX (absolute and change from baseline) with parameters indicative of renal injury (e.g., increases in plasma creatinine through Day 5 and development of oliguria, need for a nephrology consult or initiation of dialysis through Day 10). These results will assist in establishing the sensitivity and specificity of plasma and urine MIOX for the detection of meaningful kidney injury following cardiopulmonary bypass surgery.
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
- Patients undergoing cardiac surgery at BJH
Key inclusion criteria (2 listed)
- Male or female scheduled for cardiac surgery including placement of Left or Right ventricular assist devices, requiring cardiopulmonary bypass
- Age greater than or equal to 18 years
Key exclusion criteria (12 listed)
- Age less than 18 years
- Inability to obtain Informed Consent from patient or representative
- Prisoners or other institutionalized or vulnerable individuals.
- Participation in an interventional clinical study within the previous 30 days.
- History of previous renal transplantation
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
Acute Kidney Injury
Time frame: 10 days
1 secondary outcome
Renal replacement therapy
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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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.
Joseph Gaut, MD, PhD principal investigator
Washington University School of Medicine
Anitha Vijayan, MD principal investigator
Washington University School of Medicine
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 Barnes-Jewish Hospital 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 2 inclusion and 12 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 7 Aug 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anitha Vijayan, MD (3143627211, avijayan@dom.wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (time frame: 10 days). 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 7 Aug 2013; AzTrials last refreshed its copy on 8 Nov 2026.