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NCT03085615 · ClinicalTrials.gov registry record · NA
Feeding the Critically Ill During Phases of Altered Redox Status
A NA study of Oxidative Stress and Acute Respiratory Distress Syndrome, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT03085615 is a NA study of Oxidative Stress and Acute Respiratory Distress Syndrome that has completed, run by University of Illinois at Chicago. The registered enrollment target is 35 participants, below the 85-participant average among 36 other Oxidative Stress trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03085615, a NA study of Oxidative Stress and Acute Respiratory Distress Syndrome, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
The FEDOX trial is a prospective randomized clinical trial exploring oxidative stress as a mechanism of harm to explain the negative outcomes found in feeding trials that achieved caloric exposure commensurate with the nationally recommended guidelines. Due to its impact on energy metabolism, we will also explore low T3 syndrome's relationship to this mechanism. Finally, we will explore circadian patterns of diurnal/nocturnal TSH fluctuation as a potential biomarker to indicate this mechanism of harm has subsided. This 7-day prospective randomized clinical trial is designed to address the following specific aims (SA) in ICU patients (n=40) with systemic inflammatory response syndrome. SA1) Determine whether provision of enteral nutrition (EN) at 100% of levels in Nationally Recommended Guidelines NRG (25-30 kcals/kg, 100%NRG) early in critical illness increases reactive oxygen species (ROS) production compared to EN at 40% of NRG levels (10-12 kcals/kg, 40%NRG). Subjects will be fasted overnight and randomized to receive either 100% NRG or 40%NRG for 7 days. Plasma F2-isoprostanes will be measured daily and compared between groups through repeated measures analysis. SA2) Determine if EN at 100%NRG interrupts the critical illness induced low T3 syndrome and subsequently further increases the ROS production compared to 40%NRG. Serum thyroid parameters (T3, T4, rT3, TSH) with be measured daily and compared between groups as above. Mediation analysis will be used to determine the proportion of the effect of nutrition group on F2-isoprostane production explained by each thyroid parameter. SA3) Determine if the return of diurnal/noctural fluctuations in TSH is associated with decreased nutrition-induced ROS production. Plasma TSH will be measured twice per day at 0300 and 1800hrs to determine TSH fluctuation. The interaction effect between TSH fluctuation and nutrition group on F2-isoprostane production will be assessed through repeated measures analysis. This study
Conditions Studied
Interventions
- OTHER Jevity 1.5
Study Locations (1)
Illinois
- Rush University Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2017-03-15 |
| Est. Completion | 2018-10-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03085615
The ClinicalTrials.gov registry entry for NCT03085615 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 85-participant average among 36 other Oxidative Stress trials with a reported enrollment target (59% lower). The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Oxidative Stress appearing as the primary indexed condition, and to 1 intervention - of which Jevity 1.5 is the first listed.
NCT03085615 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT03085615 about?
NCT03085615 is a clinical study titled "Feeding the Critically Ill During Phases of Altered Redox Status". The FEDOX trial is a prospective randomized clinical trial exploring oxidative stress as a mechanism of harm to explain the negative outcomes found in feeding trials that achieved caloric exposure commensurate with the nationally recommended guidelines. Due to its impact on energy metabolism, we wil...
What is the current status of trial NCT03085615?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2017-03-15. Estimated completion is 2018-10-13.
What conditions does trial NCT03085615 study?
This clinical trial studies the following conditions: Oxidative Stress, Acute Respiratory Distress Syndrome, Systemic Inflammatory Response Syndrome, Euthyroid Sick Syndromes.
What interventions are being tested in trial NCT03085615?
The interventions under investigation include: Jevity 1.5 (OTHER).
Who is sponsoring clinical trial NCT03085615?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03085615 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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