MIOX for Early Detection of Acute Kidney Injury After Cardiac Surgery
Status unconfirmed
Conditions studied: Acute Kidney Injury
In brief
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.
Key facts
- Study ID
- NCT01918046
- Run by
- Barnes-Jewish Hospital
- People needed
- 100
- Starts
- 2013-07-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2013-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Barnes-Jewish Hospital — St Louis, Missouri, United States (enrolling)
Full record on ClinicalTrials.gov
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