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NCT02370186 · ClinicalTrials.gov registry record

The Role of Dysfunctional HDL in Severe Sepsis

A clinical trial, sponsored by University of Florida.

Completed
Registry status
110
Enrollment target

NCT02370186: Completed study, sponsored by University of Florida.

NCT02370186 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 110 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02370186 has completed, sponsored by University of Florida.

COMPLETED
Registry status
110 participants
Enrollment target

Study Summary

Severe sepsis results in over 300,000 Emergency Department (ED) visits and 215,000 deaths annually in the US. Currently there are no effective drug therapies for sepsis. High density lipoprotein (HDL) has antioxidant, anti-inflammatory, and antithrombotic properties and is protective in sepsis. Its functions in sepsis are primarily mediated by its main apolipoprotein, Apo-A1, that: 1) neutralize potent bacterial toxins, 2) protect blood vessel walls from damage, 3) prevent tissue damage through antioxidant properties, and 4) mediate thymocyte apoptosis (critical for survival) and endogenous corticosteroid release. However, recent literature presents inconsistent data on HDL functionality and shows that HDL becomes non-functional during acute inflammatory states called dysfunctional HDL (Dys-HDL). Several causes for Dys-HDL have been hypothesized including the presence of Apo A1 polymorphisms, which may worsen the pathologic inflammatory response in sepsis and have been demonstrated in early sepsis, making Dys-HDL an unstudied potential early marker. This project aims to: 1) determine the presence of Dys-HDL in adult patients with early severe sepsis who present to the ED (Dys-HDL will be tested using a novel cell free assay and HDL Inflammatory Index will be measured), and 2) examine the relationship between Dys-HDL and cumulative organ dysfunction via Sequential Organ Failure Assessment (SOFA) score. Results of this study could establish Dys-HDL as an early disease marker for sepsis which is influential in the development of sepsis-induced organ dysfunction.

Primary Outcome

Measure Dys-HDL in adult patients with early severe sepsis who present to the ED.

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2015-02
Est. Completion 2017-03-12
University of Florida

1,106 total trials

What the finished NCT02370186 record still lists

NCT02370186 is an observational study that tracks outcomes without assigning an intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT02370186 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02370186 about?

NCT02370186 is a clinical study titled "The Role of Dysfunctional HDL in Severe Sepsis". Severe sepsis results in over 300,000 Emergency Department (ED) visits and 215,000 deaths annually in the US. Currently there are no effective drug therapies for sepsis. High density lipoprotein (HDL) has antioxidant, anti-inflammatory, and antithrombotic properties and is protective in sepsis. Its ...

What is the current status of trial NCT02370186?

This trial is currently completed. The enrollment target is 110 participants. The study started on 2015-02. Estimated completion is 2017-03-12.

Who is sponsoring clinical trial NCT02370186?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02370186, the US trial registry maintained by the National Library of Medicine. NCT02370186 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.