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CompletedNCT03319836PROTARGETUpdated Sep 25, 2018

Meeting Protein Targets in Critically Ill Patients

An observational study in Critical Illness and Dietary Modification, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-25.

Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
40
Ages
18 Years and older
Sex
All
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Study summary

This is a retrospective study of protein and energy intake in enterally fed critically ill adult patients before and after the introduction of a very high protein enteral nutrition formula in a single center medical/surgical ICU.

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Conditions studied

  • Critical Illness
  • Dietary Modification

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03

In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's enrollment of 40 is below the median of 140 across 814 observational studies indexed under Critical Illness.

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Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult medical/surgical ICU patients that received enteral nutrition with or without a very high protein enteral nutrition formula.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients ≥ 18 years of age, mechanically ventilated
  • Received enteral nutrition for a minimum of five days during the first week of ICU admission

Exclusion criteria

Exclusion Criteria:

  • Received parenteral nutrition during first week of ICU admission
  • Acute renal failure not dialyzed
  • Hepatic encephalopathy grade 3 or 4
  • Intentional underfeeding/trophic feeding - including refeeding syndrome
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Pre-very high protein enteral nutrition

    20 enterally fed critically ill adult patients prior to the introduction of a very high protein enteral nutrition formula \[2015\].

  • Post-very high protein enteral nutrition

    20 enterally fed critically ill adult patients post the introduction of a very high protein enteral nutrition formula \[2016\].

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What researchers measure

Primary outcomes

  1. Daily total protein intake

    Daily total protein intake and percent prescribed protein needs met during first week of ICU admission.

    Time frame: Daily up to 7 days of ICU stay

Secondary outcomes

  1. Daily caloric intake - Total Calories

    Total calories aggregate from all sources

    Time frame: Daily up to 7 days of ICU stay

  2. Daily caloric intake - kcal/kg

    Total volume consumed and weight will be used to measure kcal/kg

    Time frame: Daily up to 7 days of ICU stay

  3. Daily caloric intake from enteral nutrition

    Daily caloric intake from enteral nutrition, and medications (i.e. Propofol)

    Time frame: Daily up to 7 days of ICU stay

  4. Percentage of prescribed calorie needs met

    Percentage of prescribed calorie needs met

    Time frame: Daily up to 7 days of ICU stay

  5. Feeding interruptions

    Feeding interruptions; and reason for interruption, if recorded in electronic medical record/nursing flow sheets

    Time frame: Daily up to 7 days of ICU stay

  6. Use of inotropes/vasopressors (highest daily dose prescribed)

    Use of inotropes/vasopressors will be documented as a Yes/No.

    Time frame: Daily up to 7 days of ICU stay

  7. Feeding tolerance

    Feeding tolerance as recorded by clinicians in electronic medical record/nursing flow sheets \[gastrointestinal side effects observed and documented: vomiting, elevated Gastric Residual Volumes (\>200 mL), aspiration, pneumonia, diarrhea (Bristol stool chart definition and ≥ 3 liquid stools/day)\]

    Time frame: Daily up to 7 days of ICU stay

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Study locations

1 site
  • Hamilton Health Sciences
    Hamilton, Ontario L8L 8E7, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2017 to primary completion in Feb 2018, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2017
First posted
Oct 24, 2017
StartActual
Oct 4, 2017
Primary completionActual
Feb 16, 2018
CompletionActual
Feb 16, 2018
Last update
Sep 25, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03319836
Responsible party
Sponsor
First posted
Oct 24, 2017
Start date
Oct 4, 2017
Primary completion
Feb 16, 2018
Completion
Feb 16, 2018
Last update
Sep 25, 2018

Study contacts

Michele ApSimon
principal investigator · Hamilton Health Sciences Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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