Status:
UNKNOWN
MIOX for Early Detection of Acute Kidney Injury After Cardiac Surgery
Lead Sponsor:
Barnes-Jewish Hospital
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
18+ years
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 acu...
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
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Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01918046
Start Date
July 1 2013
End Date
September 1 2014
Last Update
August 7 2013
Active Locations (1)
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1
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110