An interventional study of Jevity 1.5 in Acute Respiratory Distress Syndrome, Oxidative Stress and Euthyroid Sick Syndromes, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Supportive care
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 provides vital mechanistic insight into the impact of feeding on oxidative stress during the first week of critical illness, represents an important first step in determining the safest timing and dosage of nutrition support, and sets the foundation for future larger clinical trials on these topics.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
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Inclusion Criteria:
Exclusion Criteria: Patients will be excluded if the are pregnant, have documented neurologic disease prior to admission that interferes with the capacity to give informed consent or do not require EN for their nutritional care.
Patient will receive the enteral nutrition product Jevity 1.5 starting at 20mL per hour and increasing by 20mL every four hours until a goal rate delivering 25-30kcals/kg is achieved. If feeding is interrupted, flow rate will be adjusted to compensate for nutritional loss.
Other: Jevity 1.5
Patient will receive the enteral nutrition product Jevity 1.5 starting at 20mL per hour and increasing by 20mL every four hours until a goal rate delivering 12-14 kcals/kg is achieved. If feeding is interrupted, flow rate will be adjusted to compensate for nutritional loss.
Other: Jevity 1.5
Jevity 1.5 is an enteral nutrition product delivering 1.5 kcals/mL and 0.06 g protein/mL.
Daily Plasma F2-Isoprostane levels
Plasma maximum concentration of F2-isoprostanes will be quantified through liquid chromatography tandem mass spectrometry (LC-MS/MS) of plasma using a Q-trap mass spectrometer.
Time frame: 7 days
Thyroid Stimulating Hormone (TSH)
TSH will be measured twice per day using commercially available immuno-assay kits.
Time frame: 7 days
Triiodothyronine (T3)
T3 will be measured daily using commercially available immuno-assay kits.
Time frame: 7 days
Thyroxine (T4)
T4 will be measured daily using commercially available immuno-assay kits.
Time frame: 7 days
Reverse Triiodothyronine (rT3)
rT3 will be measured daily using commercially available immuno-assay kits.
Time frame: 7 days
Plan to share: Undecided
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
University of Illinois at Chicago