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NCT01966237 · ClinicalTrials.gov registry record
Milrinone Pharmacokinetics and Acute Kidney Injury
A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- 92
- Enrollment target
NCT01966237: Completed study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01966237 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 92 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01966237 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- 92 participants
- Enrollment target
Study Summary
Acute kidney injury (AKI) occurs in 40% of children following heart surgery. Serum creatinine (Scr) is a late biomarker of AKI, rising 24-48 hours after surgery. Thus, for medicines excreted in the urine, AKI could potentially lead to toxic levels in the blood. Urinary biomarkers have the ability to detect AKI earlier. Whether early detection of AKI through urinary biomarkers can predict altered drug levels is unknown. Milrinone is used to improve heart function after surgery, but accumulates in AKI resulting in low blood pressure. Dose adjustments are not currently possible because of the late rise in SCr, and are based on clinical parameters that may lead to clinically relevant over or under-dosing. Thus, this study will address an important knowledge gap being the first to use elevations of AKI biomarker concentrations to anticipate increased milrinone levels.
Primary Outcome
The primary outcome variables for Aim 1 are an elevation in urinary AKI biomarkers to predict a 25% reduction in milrinone clearance.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2013-09 |
| Est. Completion | 2018-07 |
What the finished NCT01966237 record still lists
NCT01966237 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 92 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01966237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01966237 about?
NCT01966237 is a clinical study titled "Milrinone Pharmacokinetics and Acute Kidney Injury". Acute kidney injury (AKI) occurs in 40% of children following heart surgery. Serum creatinine (Scr) is a late biomarker of AKI, rising 24-48 hours after surgery. Thus, for medicines excreted in the urine, AKI could potentially lead to toxic levels in the blood. Urinary biomarkers have the ability to...
What is the current status of trial NCT01966237?
This trial is currently completed. The enrollment target is 92 participants. The study started on 2013-09. Estimated completion is 2018-07.
Who is sponsoring clinical trial NCT01966237?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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