REDOXS FAQ Log
Category Sub Category Question Response
The patient must be screened AND consent must be
obtained within 24 hrs of ICU admission since supplements
need to be started soon after admission to ICU. If it takes
too long to obtain consent, this patient should NOT be
How much time do we have to obtain consent? Is it 24 hrs randomized as there will be an unacceptable delay in
Consent n/a from ICU admission? starting study supplements.
No, these patients are eligible. It is understood that given
the patient’s organ failures, enteral feeds may not be
tolerated or it may be difficult to ascertain how well the
patient is going to tolerate enteral feeds. Either way, these
patients should not be excluded unless they meet an
What about patients in which it is difficult to assess with exclusion criteria (i.e. absolute contraindication to enteral
precision the tolerance to enteral feeding? Should these nutrition). Remember, the study supplements are nutrients
patients be excluded if feeds are not expected to be that are infused at low rates, they are very well absorbed
Eligibility n/a tolerated? even in patients that are not tolerating enteral nutrition.
Yes, but ONLY if the organ failures are considered to be
acute at this admission and are NOT a continuation from the
previous admission to ICU. Also, remember that previous
Is the patient that was admitted to ICU 2 weeks ago, was randomization in the REDOXS study means the patient is
Eligibility n/a discharged and is not re-admitted to ICU eligible? excluded at all subsequent admissions.
Yes, a patient who has cancer is eligible as long as it is not
Eligibility n/a Is a patient who has cancer eligible? metastatic cancer or stage 4 lymphoma.
For a patient with Chronic Lung Disease that may have a
chronic low PF ratio, do we need to pick 2 other organ No, for the patient with Chronic Lung Disease, a PF ration 72 hours
Eligibility n/a randomization? prior to ICU admission, it may NOT be considered acute.
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Category Sub Category Question Response
No, the actual time of admission to ICU is the ICU admission
time. The 24 hour window starts from the actual ICU
admission, not the time they were in the step-down ICU
waiting for an ICU bed, even if they were ventilated in the
step-down unit. For inclusion, the failures have to be present
Some patients are admitted initially to step-down ICU and in the ICU, even if they started in the step-down unit. The
later they are transferred to the ICU. Is the step-down ICU timing of the organ failure is onset of organ failure. For
considered as an ICU stay and should the time in the step- example, for the PF ratio, use the first ratio
48 hours from ICU discharge. As outlined in the REDOXS
Implementation Manual (page 7), if a patient is readmitted to
your ICU WITHIN 48 HOURS of discharge, consider this to
be a continuation of the previous stay. Restart the study
supplements and continue to collect data and consider the
reason for readmission to ICU as a Serious Adverse Event.
If the patient is readmitted to your ICU after 48 hours of
What documentation is required if a REDOXS patient is re- discharge, this is not considered to be a continuation of the
Data Collection Re-admission admitted to the ICU > 48 hours after the ICU discharge? previous stay.
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Category Sub Category Question Response
(1) If enteral nutrition continues past ICU discharge, then
enteral nutrition stop date/time = ICU discharge date/time
(pg. 29 of Implementation Manual)
(2) If the patient is still in the ICU past day 30 and is still
What is the enteral nutrition stop date? receiving enteral nutrition, the enteral nutrition stop date/time
(1) If the patient continues enteral feeds after being = day 30 date/time. Enteral nutrition stop time is the time
discharged from ICU? your flowsheet ends.
(2) If the patient remains in the ICU beyond day 30 and is In both cases, please enter the actual enteral nutrition stop
still receiving enteral feeds? date in the comments field.
Data Collection Daily Nutrition
If the patient is extubated and remains in the ICU, you must
submit a PV for that day only. Indicate on the PL that re-
insertion of the tube was not clinically indicated.
If on the day of extubation the patient receives 6
hrs within your 24 hr flowsheet period (i.e. within a study
day). If the propofol is infused for < 6 hours or is an
intermittent dose the calories from propofol SHOULD NOT
be included in PN Total Energy. If is not requried to
seperately identify the propofol on the eCRF, but the site
dietitian may want to keep record of the energy contribution
A number of you have inquired about the contribution fo from propofol on her daily work sheet in case a discrepancy
Data Collection Propofol propofol calories to total energy. is found during source verification.
If seizures occur in the ICU and the patient needs
anticonvulsants and there is no documented history or
seizures needing anticonvulsants prior to this illness, this
patient is eligible. Patients with acute seizures requiring
Are patients who have had an ACUTE seizure requiring anticonvulsants are eligible yet patients with a history of
Eligibility Seizures anticonvulsants eligible for the study? seizures requiring anticonvulsants are an exclusion.
Once opened, the bag of parenteral study supplements is
good for 24 hours only. You may change the IV tubing as
per your hospital's standard protocol. This is done at varying
frequencies depending on your institution (usually anywhere
At what frequency should we change the IV tubing for from 24-72 hours). For further detail, refer to the
Study Supplements IV tubing parenteral study supplements? Administration of Study Supplements Manual, page 8.
When a patient is extubated, receiving parenteral nutrition No need to calculate calories and protein from oral feeding.
and eating a little bit, do we need to calculate the amount of We only need the calories and protein for parenteral and
Nutrition Oral Feeding calories and proteins from oral feeding? enteral nutrition.
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REDOXS FAQ Log
Category Sub Category Question Response
If a patient is discharged to the floor before the patient has
received 5 days of study supplements, then study
We had a patient that was discharged from ICU to the floor supplements would be continued on the floor to achieve the
after being on study supplements for 2 weeks. Our 5 days. Given this scenerio, since the patient has already
pharmacist was asking if study supplements could be received 5 days of study supplements they should not be
continued on the floor as long as the site investigator was given study supplements on the floor, the duration cannot be
Study Supplements After Discharge from ICU agreeable? extended at the discretion of the Site Investigator.
We define mechanical ventilation as intubation with
mechanical ventilation or tracheostomy with mechanical
ventilation. This includes any positive pressure delivered via
endotracheal tube or a tracheostomy. This does not refer to
non-invasive methods of ventilation such as BiPAP or mask-
CPAP unless non-invasive ventilation (e.g. BiPAP, CPAP) is
If a patient is extubated but on BiPAP, is this considered delivered through a tracheostomy (if latter, then considered
Eligibility n/a mechanical ventilation for the purpose of the study? invasive mechanical ventilation.
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Consent
Eligibility
EDC System
Study Supplements
Nutrition
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Data Collection
Pharmacy
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