Critical IllnessPROTARGETNCT03319836
Meeting Protein Targets in Critically Ill Patients
An observational study of Critical Illness and Dietary Modification, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Dietary Modification
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 4 Oct 2017to 16 Feb 2018
- Phase
- Observational
- 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
Study population: Adult medical/surgical ICU patients that received enteral nutrition with or without a very high protein enteral nutrition formula.
Who may be able to join
- Adult patients ≥ 18 years of age, mechanically ventilated
- Received enteral nutrition for a minimum of five days during the first week of ICU admission
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Meeting Protein Targets in Critically Ill Patients: A Retrospective Analysis
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.
- Conditions
- Critical Illness, Dietary Modification
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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]. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily total protein intake
Daily total protein intake and percent prescribed protein needs met during first week of ICU admission.
Measured: Daily up to 7 days of ICU stay
Secondary outcomes (7)
Daily caloric intake - Total Calories
Total calories aggregate from all sources
Measured: Daily up to 7 days of ICU stay
Daily caloric intake - kcal/kg
Total volume consumed and weight will be used to measure kcal/kg
Measured: Daily up to 7 days of ICU stay
Daily caloric intake from enteral nutrition
Daily caloric intake from enteral nutrition, and medications (i.e. Propofol)
Measured: Daily up to 7 days of ICU stay
Percentage of prescribed calorie needs met
Percentage of prescribed calorie needs met
Measured: Daily up to 7 days of ICU stay
Feeding interruptions
Feeding interruptions; and reason for interruption, if recorded in electronic medical record/nursing flow sheets
Measured: Daily up to 7 days of ICU stay
Use of inotropes/vasopressors (highest daily dose prescribed)
Use of inotropes/vasopressors will be documented as a Yes/No.
Measured: Daily up to 7 days of ICU stay
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)]
Measured: Daily up to 7 days of ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start4 Oct 2017
- Primary completion16 Feb 2018
- Study completion16 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Michele ApSimon, Principal investigator, Hamilton Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319836
- Sponsor's protocol ID
- 16.02.CA.HCN
- Acronym
- PROTARGET
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2017
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meeting Protein Targets in Critically Ill Patients: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03319836
- Acronym / sponsor ID
- PROTARGET / 16.02.CA.HCN
- Conditions
- Critical Illness, Dietary Modification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 16 Feb 2018 (actual)
- Study completion
- 16 Feb 2018 (actual)
- First posted
- 24 Oct 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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]. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult medical/surgical ICU patients that received enteral nutrition with or without a very high protein enteral nutrition formula.
Key inclusion criteria (2 listed)
- Adult patients ≥ 18 years of age, mechanically ventilated
- Received enteral nutrition for a minimum of five days during the first week of ICU admission
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Daily total protein intake
Time frame: Daily up to 7 days of ICU stay
Daily total protein intake and percent prescribed protein needs met during first week of ICU admission.
7 secondary outcomes
Daily caloric intake - Total Calories
Time frame: Daily up to 7 days of ICU stay
Daily caloric intake - kcal/kg
Time frame: Daily up to 7 days of ICU stay
Daily caloric intake from enteral nutrition
Time frame: Daily up to 7 days of ICU stay
Percentage of prescribed calorie needs met
Time frame: Daily up to 7 days of ICU stay
Feeding interruptions
Time frame: Daily up to 7 days of ICU stay
Use of inotropes/vasopressors (highest daily dose prescribed)
Time frame: Daily up to 7 days of ICU stay
Feeding tolerance
Time frame: Daily up to 7 days of ICU stay
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 25 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Michele ApSimon principal investigator
Hamilton Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Dietary Modification, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
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 4 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 25 Sep 2018. 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 Canada. 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 total protein intake (time frame: Daily up to 7 days of ICU stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2018.