Acute Respiratory Distress SyndromeFEDOXNCT03085615
Feeding the Critically Ill During Phases of Altered Redox Status
A study testing Jevity 1.5 in people with Acute Respiratory Distress Syndrome and Oxidative Stress, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Oxidative Stress, Euthyroid Sick Syndromes
- What is being tested?
- Jevity 1.5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2017to 13 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Feeding the Critically Ill During Phases of Altered Redox Status (FEDOX): a Prospective Randomized Trial
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.
Read more
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.
- Conditions
- Acute Respiratory Distress Syndrome, Oxidative Stress, Euthyroid Sick Syndromes, Systemic Inflammatory Response Syndrome
- Being tested
- Jevity 1.5
- Medical subject headings
- Respiratory Distress Syndrome, Euthyroid Sick Syndromes, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jevity 1.5Other
Jevity 1.5 is an enteral nutrition product delivering 1.5 kcals/mL and 0.06 g protein/mL.
| Study group | Role | What they receive |
|---|---|---|
| 100%NRG | Experimental | 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. Receives: Other: Jevity 1.5 |
| 40%NRG | Active comparator | 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. Receives: Other: Jevity 1.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (4)
Thyroid Stimulating Hormone (TSH)
TSH will be measured twice per day using commercially available immuno-assay kits.
Measured: 7 days
Triiodothyronine (T3)
T3 will be measured daily using commercially available immuno-assay kits.
Measured: 7 days
Thyroxine (T4)
T4 will be measured daily using commercially available immuno-assay kits.
Measured: 7 days
Reverse Triiodothyronine (rT3)
rT3 will be measured daily using commercially available immuno-assay kits.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start15 Mar 2017
- Primary completion4 Jun 2018
- Study completion13 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Parenteral and Enteral Nutrition, Rush University Medical Center
- Responsible party
- Principal investigator, Liam McKeever, University of Illinois Chicago
- Investigators
- Liam B McKeever, MS, PhD(c), Principal investigator, University of Illinois ChicagoCarol A Braunschweig, PhD, Study director, Uinversity of Illinois at ChicagoOmar Lateef, DO, Study chair, Rush University Medical CenterMarcelo Bonini, PhD, Study chair, University of Illinois ChicagoAntonio Bianco, MD, PhD, Study chair, Rush University Medical CenterSarah J Peterson, PhD, Study chair, Rush University Medical CenterAlan Diamond, PhD, Study chair, University of Illinois ChicagoSally Freels, PhD, Study chair, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085615
- Sponsor's protocol ID
- FEDOX
- Acronym
- FEDOX
- Status last verified
- Apr 2019
- First submitted
- 15 Mar 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McKeever L, Peterson SJ, Cienfuegos S, Rizzie J, Lateef O, Freels S, Braunschweig CA. Real-Time Energy Exposure Is Associated With Increased Oxidative Stress Among Feeding-Tolerant Critically Ill Patients: Results From the FEDOX Trial. JPEN J Parenter Enteral Nutr. 2020 Nov;44(8):1484-1491. doi: 10.1002/jpen.1776. Epub 2020 Jan 29.
PubMed 31995239McKeever L, Peterson SJ, Lateef O, Freels S, Fonseca TL, Bocco BMLC, Fernandes GW, Roehl K, Nowak K, Mozer M, Bianco AC, Braunschweig CA. Higher Caloric Exposure in Critically Ill Patients Transiently Accelerates Thyroid Hormone Activation. J Clin Endocrinol Metab. 2020 Feb 1;105(2):523-33. doi: 10.1210/clinem/dgz077.
PubMed 31581295
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding the Critically Ill During Phases of Altered Redox Status (FEDOX): a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03085615
- Acronym / sponsor ID
- FEDOX / FEDOX
- Conditions
- Acute Respiratory Distress Syndrome, Oxidative Stress, Euthyroid Sick Syndromes, Systemic Inflammatory Response Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- American Society for Parenteral and Enteral Nutrition, Rush University Medical Center
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 13 Oct 2018 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 100%NRG | Experimental | Other: Jevity 1.5Patient 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. |
| 40%NRG | Active comparator | Other: Jevity 1.5Patient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jevity 1.5Jevity 1.5 is an enteral nutrition product delivering 1.5 kcals/mL and 0.06 g protein/mL. | Other | 100%NRG, 40%NRG |
Primary outcome
Daily Plasma F2-Isoprostane levels
Time frame: 7 days
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.
4 secondary outcomes
Thyroid Stimulating Hormone (TSH)
Time frame: 7 days
Triiodothyronine (T3)
Time frame: 7 days
Thyroxine (T4)
Time frame: 7 days
Reverse Triiodothyronine (rT3)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 31995239McKeever L, Peterson SJ, Cienfuegos S, Rizzie J, Lateef O, Freels S, Braunschweig CA. Real-Time Energy Exposure Is Associated With Increased Oxidative Stress Among Feeding-Tolerant Critically Ill Patients: Results From the FEDOX Trial. JPEN J Parenter Enteral Nutr. 2020 Nov;44(8):1484-1491. doi: 10.1002/jpen.1776. Epub 2020 Jan 29.
- Derived from this study: PubMed 31581295McKeever L, Peterson SJ, Lateef O, Freels S, Fonseca TL, Bocco BMLC, Fernandes GW, Roehl K, Nowak K, Mozer M, Bianco AC, Braunschweig CA. Higher Caloric Exposure in Critically Ill Patients Transiently Accelerates Thyroid Hormone Activation. J Clin Endocrinol Metab. 2020 Feb 1;105(2):523-33. doi: 10.1210/clinem/dgz077.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liam B McKeever, MS, PhD(c) principal investigator
University of Illinois Chicago
Carol A Braunschweig, PhD study director
Uinversity of Illinois at Chicago
Omar Lateef, DO study chair
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jevity 1.5 in people with Acute Respiratory Distress Syndrome and Oxidative Stress, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Plasma F2-Isoprostane levels (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03085615, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.