Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-16

Study Completion Date

2019-09-10

Brief Summary

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In this study, we will explore the feasibility of a randomized controlled trial that will compare high protein dose from ICU day 6 to 14 with moderate protein intake.

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Detailed Description

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Patients will be recruited on day 1-2 of ICU admission. On day 5, patients will be randomized into one of the two intervention arms;

Replenish Protein group:

Patients randomized to this group will receive 2 g of protein/kg/day (acceptable range 1.8 - 2.2 g of protein/kg/day) for day 6-14.

Standard Protein group:

Patients randomized to this group will receive protein at 0.8 - 1.0 g of protein/kg/day for day 6-14

Conditions

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Critical Illness ARDS Septic Shock Multiple Trauma Seizure Disorder Hemorrhagic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Replenish Protein group

Subjects randomized to this group will receive 2 g of protein/kg/day (acceptable range as 1.8 - 2.2 g of protein/kg/day) for day 6-14.

Group Type ACTIVE_COMPARATOR

Replenish Protein

Intervention Type DIETARY_SUPPLEMENT

Subjects randomized to this group will receive 2 g of protein/kg/day (acceptable range as 1.8 - 2.2 g of protein/kg/day) for day 6-14.

Standard Protein group

Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14

Group Type OTHER

Standard protein

Intervention Type DIETARY_SUPPLEMENT

Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14

Interventions

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Replenish Protein

Subjects randomized to this group will receive 2 g of protein/kg/day (acceptable range as 1.8 - 2.2 g of protein/kg/day) for day 6-14.

Intervention Type DIETARY_SUPPLEMENT

Standard protein

Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Intervention group Control group

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
2. Mechanically ventilated
3. Receiving enteral feeding via nasogastric/orogastric or duodenal or PEG or jejunostomy tubes and
4. Expected to stay ≥ 1 week in the ICU

Exclusion Criteria

1. Lack of commitment to ongoing life support, which includes;

* Terminal Illness (Malignancy or irreversible condition with 6 month mortality \> 50%)
* DNR order in the first 48 hours and brain death within 48 hours of admission) (Don't include the presence of a "Do Not Resuscitate" order alone, if there is a commitment to ongoing life support).
2. Patients not fed within 48 hours of admission
3. Patients on total parenteral nutrition (TPN)
4. Patients being fed orally
5. Chronic renal failure
6. Chronic liver disease
7. Renal replacement therapy
8. Pregnancy.
9. Kidney transplant
10. Post-liver transplant.
11. Post cardiac arrest.
12. Burn patients.
13. Prisoners

Screened patients will be screened again for eligibility at day 5, should be mechanically ventilated and expected to stay ≥ 3 days in the ICU. At this point, patients will be excluded if they meet the following;

1. New onset renal replacement therapy.
2. Acute Kidney Injury (serum creatinine \> 3 times the preacute level or serum creatinine \>350mmol/L with a recent increase of \>44 mmols/L)
3. Significant liver impairment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No