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NCT01382758 · ClinicalTrials.gov registry record
Near Infrared Spectroscopy for the Detection of Acute Kidney Injury in Children Following Cardiac Surgery
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 107
- Enrollment target
NCT01382758: Completed study, sponsored by University of Colorado, Denver.
NCT01382758 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 107 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01382758 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 107 participants
- Enrollment target
Study Summary
One in a hundred children is born with a heart defect. Some children require heart surgery within the first few days of life, while others can wait until they are older. A complication of open-heart surgery is low blood flow due to the heart-lung machine that can cause sudden loss of kidney function known as acute kidney injury (AKI). AKI causes complications that can increase hospital length of stay and increase risk of death. Current ways to identify AKI are not able to it until 2 or 3 days after it has occurred. Because of this, there is not a specific treatment for AKI. If the investigators diagnose AKI early, they might be able to treat it and improve outcomes in children. NIRS is a skin monitor that can detect low blood flow to the kidney and might help diagnose AKI when it occurs in the operating room. The use of NIRS to diagnose AKI early is the focus of this study.
Primary Outcome
A decline in intra-operative renal NIRS to predict AKI as measured by an increase in serum creatinine. Baseline lab testing, including BMP, UA. Renal NIRS sensors will be placed prior surgery. In the OR, continuous real time monitoring of NIRS will occur and continue for 72 hours after cardiopulmonary bypass (CPB). BMP will be performed after surgery and at 24, 48 and 72 hours. Repeat UA will be performed at 24 hours post CPB, and urine electrolytes and urea will be performed at 12, 24, 48 and 7
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-01 |
What the finished NCT01382758 record still lists
NCT01382758 is an observational study that tracks outcomes without assigning an intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01382758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01382758 about?
NCT01382758 is a clinical study titled "Near Infrared Spectroscopy for the Detection of Acute Kidney Injury in Children Following Cardiac Surgery". One in a hundred children is born with a heart defect. Some children require heart surgery within the first few days of life, while others can wait until they are older. A complication of open-heart surgery is low blood flow due to the heart-lung machine that can cause sudden loss of kidney function...
What is the current status of trial NCT01382758?
This trial is currently completed. The enrollment target is 107 participants. The study started on 2011-07. Estimated completion is 2013-01.
Who is sponsoring clinical trial NCT01382758?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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