Feeding the Critically Ill During Phases of Altered Redox Status

Feeding the Critically Ill During Phases of Altered Redox Status (FEDOX): a Prospective Randomized Trial

Sponsors

Lead Sponsor: University of Illinois at Chicago

Collaborator: American Society for Parenteral and Enteral Nutrition
Rush University Medical Center

Source University of Illinois at Chicago
Brief 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 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.

Overall Status Completed
Start Date 2017-03-15
Completion Date 2018-10-13
Primary Completion Date 2018-06-04
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Daily Plasma F2-Isoprostane levels 7 days
Secondary Outcome
Measure Time Frame
Thyroid Stimulating Hormone (TSH) 7 days
Triiodothyronine (T3) 7 days
Thyroxine (T4) 7 days
Reverse Triiodothyronine (rT3) 7 days
Enrollment 35
Condition
Intervention

Intervention Type: Other

Intervention Name: Jevity 1.5

Description: Jevity 1.5 is an enteral nutrition product delivering 1.5 kcals/mL and 0.06 g protein/mL.

Eligibility

Criteria:

Inclusion Criteria: - Adult patients (>18 years) admitted to RUMC MICU who are able to receive EN, who have two consecutive white blood cell lab values above 12,000/mm^3 or below 4,000/mm^3 plus at least one of the following 3 criteria met for at the past 12 hours will be eligible for participation. Criteria: (1) a respiratory rate greater than 20 breaths per minute or PaCO2 less than 32mmHg, (2) a heart rate greater than 90 beats per minute, or (3) a temperature greater than 100.4F or less than 96.8F. 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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Location
Facility: Rush University Medical Center
Location Countries

United States

Verification Date

2019-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Illinois at Chicago

Investigator Full Name: Liam McKeever

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 100%NRG

Type: Experimental

Description: 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.

Label: 40%NRG

Type: Active Comparator

Description: 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.

Acronym FEDOX
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Subjects will be randomized to receive either 25-30 kcals/kg or 12-14 kcals/kg. They will be followed for a maximum of 7 days or until ICU discharge. Blood draws will occur twice daily.

Primary Purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Masking Description: Only our lab technicians will be truly blinding to group allocation.

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