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Critically IllPEP-uPNCT01102348

Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients

A study testing PEP-uP Protocol in people with Critically Ill, run by Daren K. Heyland at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this pilot study is to assess the feasibility, acceptability, and safety of a new feeding protocol, "The Enhanced Protein-Energy Provision via the Enteral Route in Critically Ill Patients: The PEP uP protocol." Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critically Ill
What is being tested?
PEP-uP Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteCanada
Study dates
Jun 2008to Jul 2009
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

  • Mechanically ventilated within 48 hours of admission to the intensive care unit

Who cannot join

  • Less than 72 hours in intensive care unit before discharge

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

Other trials in Canada

About this study

Official title: Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients: A Single Center Feasibility Trial of The PEP uP Protocol

The purpose of this pilot study is to assess the feasibility, acceptability, and safety of a new feeding protocol, "The Enhanced Protein-Energy Provision via the Enteral Route in Critically Ill Patients: The PEP uP protocol."

Read the detailed description

There is a well known and well described relationship between malnutrition, immune dysfunction, and infection. Critically ill patients are often hypermetabolic and can rapidly become nutritionally compromised. Repeated efforts over the past few years have not significantly improved the amount of calories delivered via the enteral route. Historically, feeding protocols have been used to guide the delivery of enteral nutrition (EN) but they frequently utilize conservative, reactionary approaches to optimizing nutrition.

We propose a new approach that protocolizes an aggressive approach to providing EN and shifts the paradigm from reactionary to proactive followed by de-escalation if nutrition therapy is not needed. The key components of this new protocol are the following: 1) Starting feeds at the target rate based on increasing evidence that some patients tolerate starting nutrition at higher rate of delivery and that slow start ups are not necessary. For patients who are hemodynamically stable, we propose to shift from an hourly rate target goal to a 24 hour volume goal and give nurses guidance on how to make up this volume if there was an interruption for non-gastrointestinal reasons. This 'volume-based' goal represents a significant shift in practice from traditional hourly rate goals in which nurses can increase the hourly rate depending on how many hours they have left in the day to ensure that the patient receives the 24 hour volume within the day. 2) For patients who are deemed unsuitable for high volume intragastric feeds, we provide an option to initiate 'trophic feeds' at a low volume of a concentrated feeding solution. By 'trophic', we mean a minimal volume of EN designed to maintain gastrointestinal structure and function, not designed to meet the patients caloric or protein needs. When deemed suitable, trophic feeds can be advanced to full feeds. 3) Rather than wait for a protein debt to accumulate because of inadequate delivery of EN, protein supplements are prescribed at initiation of EN and can be discontinued if EN is well tolerated. 4) We propose to start motility agents at the same time EN is started with a re-evaluation in the days following to see if it is necessary and we raised our gastric residual volume threshold from 200 to 250 ml. It has been shown in one randomized trial that a feeding protocol that starts a motility agent empirically at the time of initiation of feeds and uses a higher threshold for a critical gastric residual volume (250 ml) improves nutritional adequacy.

Since the bedside nurses initiate and utilize feeding protocols to achieve target goals, we will couple this newer generational feeding protocol with a comprehensive nurse-directed nutritional educational intervention that will focus on its safe and effective implementation. This focus on nursing nutrition education represents a major shift away from traditional education which has focused on dietitians and physicians.

We hypothesize that the combination of these components will safely improve the provision of energy and protein compared to usual care. We postulate that this increased provision of calories and protein may translate into improved clinical outcomes, particularly for the patients at the extremes of weight, but the current study is not powered to demonstrate such a difference. The purpose of this pilot study is to assess the feasibility, acceptability, and safety of this new feeding protocol, "The Enhanced Protein-Energy Provision via the Enteral Route in Critically Ill Patients: The PEP uP protocol."

Conditions
Critically Ill
Being tested
PEP-uP Protocol
Keywords
Critically Ill, Nutrition Therapy, Enteral Nutrition
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEP-uP ProtocolOther

    Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) were made available to all nurses, in bedside manuals and on the local intranet

Study groups in NCT01102348
Study groupRoleWhat they receive
PEP-uP Protocol (after)ExperimentalPEP-uP protocol and treatment algorithm implemented for all patients in ICU.
Receives: Other: PEP-uP Protocol
Standard feeding protocol (before)No interventionEnteral feeds are guided by a standard feeding protocol specified by pre-printed ICU admission orders. The admitting physician has the option of initiating the enteral feeding protocol or keeping the patient nil per os (NPO).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the feeding protocol

    The primary outcome of this pilot study was the feasibility of the new feeding protocol as judged by a nursing questionnaire that evaluates their opinion of its safety and acceptability.

    Measured: 10-12 months

Secondary outcomes (5)
  1. Adequacy of EN

    Calculated as proportion of EN received versus EN prescribed

    Measured: 10-12 months

  2. Episodes of vomiting

    Safety endpoints

    Measured: 10-12 months

  3. Timeliness of initiation of EN

    Actual timing of EN start

    Measured: 10-12 months

  4. Episodes of aspiration

    Safety end points

    Measured: 10-12 months

  5. Episodes of aspiration & pneumonia

    Safety end points

    Measured: 10-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2010 (estimated)
  2. Study startJun 2008
  3. Primary completionMay 2009
  4. Study completionJul 2009

Resources

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
Non-randomised
Intervention model
Sequential
Model description
Before and after
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01102348
Sponsor's protocol ID
PEP-uP Pilot
Acronym
PEP-uP
Status last verified
Dec 2020
First submitted
9 Apr 2010
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
No

Publications

  • Heyland DK, Cahill NE, Dhaliwal R, Wang M, Day AG, Alenzi A, Aris F, Muscedere J, Drover JW, McClave SA. Enhanced protein-energy provision via the enteral route in critically ill patients: a single center feasibility trial of the PEP uP protocol. Crit Care. 2010;14(2):R78. doi: 10.1186/cc8991. Epub 2010 Apr 29.

    PubMed 20429886

Questions about this trial

What is this clinical trial studying?

A study testing PEP-uP Protocol in people with Critically Ill, run by Daren K. Heyland 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 1 inclusion and 1 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 17 Dec 2020. 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?

Feasibility of the feeding protocol (time frame: 10-12 months). 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 NCT01102348, which also lists 1 linked publication.

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 17 Dec 2020.

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