MIOX for Early Detection of Acute Kidney Injury After Cardiac Surgery
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 30, 2013
CompletedFirst Posted
Study publicly available on registry
August 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedAugust 7, 2013
August 1, 2013
1 year
July 30, 2013
August 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute Kidney Injury
10 days
Secondary Outcomes (1)
Renal replacement therapy
10 days
Eligibility Criteria
Patients undergoing cardiac surgery at BJH
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Biospecimen
Only for analysis of biomarker
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Gaut, MD, PhD
Washington University School of Medicine
- PRINCIPAL INVESTIGATOR
Anitha Vijayan, MD
Washington University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
July 30, 2013
First Posted
August 7, 2013
Study Start
July 1, 2013
Primary Completion
July 1, 2014
Study Completion
September 1, 2014
Last Updated
August 7, 2013
Record last verified: 2013-08