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NCT01489475 · ClinicalTrials.gov registry record
Plasma Angiopoietin Levels in Children Following Cardiopulmonary Bypass
A clinical trial, sponsored by Yale University.
- Completed
- Registry status
- 31
- Enrollment target
NCT01489475: Completed study, sponsored by Yale University.
NCT01489475 is a clinical trial that has completed, run by Yale University. The registered enrollment target is 31 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01489475 has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- 31 participants
- Enrollment target
Study Summary
During cardiopulmonary bypass (CPB) after heart surgery, a child's blood is exposed to many foreign entities. These conditions trigger the body's inflammatory response which results in leaky capillaries, increased swelling and possibly organ dysfunction. Since the early 1990's, modified ultrafiltration (MUF) has been shown to decrease excess swelling, reduce bleeding, improve heart function, and decrease hospital length of stay. Angiopoietins are a family of proteins necessary for both normal and abnormal blood vessel formation. They also appear to play a role in capillary leak. Though MUF has been shown to improve clinical outcome following CPB, there continues to be conflicting reports whether this is a result of the filtration of inflammatory proteins or simply from excess fluid removal. Since angiopoietins appear to play a role in both inflammation and capillary leak, the investigators hypothesize that the benefit seen after MUF is also secondary to its ability to filter out these proteins, especially angiopoietin-2.
Primary Outcome
Modified ultrafiltration (MUF) is the process after cardiopulmonary bypass during which a filtration unit is added and blood is filtered and returned back to the patient. The goal of this project is to evaluate the effect of MUF on concentrations of Angiopoietin-2 (Ang-2) and IL 8, two known pro-inflammatory markers involved in capillary leakage, as well as Ang-1 and IL 10, two anti-inflammatory mediators. Levels will be drawn prior to bypass, after MUF and at ICU admission.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-06 |
What the finished NCT01489475 record still lists
NCT01489475 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 31 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01489475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01489475 about?
NCT01489475 is a clinical study titled "Plasma Angiopoietin Levels in Children Following Cardiopulmonary Bypass". During cardiopulmonary bypass (CPB) after heart surgery, a child's blood is exposed to many foreign entities. These conditions trigger the body's inflammatory response which results in leaky capillaries, increased swelling and possibly organ dysfunction. Since the early 1990's, modified ultrafiltrat...
What is the current status of trial NCT01489475?
This trial is currently completed. The enrollment target is 31 participants. The study started on 2011-11. Estimated completion is 2013-06.
Who is sponsoring clinical trial NCT01489475?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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