AzTrials
AzTrials

Critically IllPEPuPNCT01167595

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 Clinical Evaluation Research Unit at Kingston General Hospital at 18 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

Critically ill patients are consistently underfed. Feeding protocols are standardized system tools used to guide nutrition practices, but to date have failed to improve delivery of nutrition. The PEP uP Protocol is a new enhanced feeding 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
1,059 participants
Where
18 sitesin 2 countries
Study dates
Sep 2010to Nov 2011
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Critically ill adults (i.e. >18 years of age)
  • Mechanically ventilated before or within the first 6 hours of admission to ICU

Who cannot join

  • Nutrition (either EN or Parenteral Nutrition (PN)) started before admission to ICU
  • Not intubated within 6 hours of admission to ICU
  • Receiving non-invasive ventilation (i.e. mask ventilation) during the first 6 hours of ICU stay
  • Moribund (as evidenced by death within 48 hours of admission to ICU)

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

United States9 sites
  • Henry Ford Macomb Hospital

    Clinton Township, Michigan

  • Nassau University Medical Center

    East Meadow, New York

  • Lakes Region General Hospital

    Laconia, New Hampshire

  • Medical Center of the Rockies

    Loveland, Colorado

  • Phoenix Veterans Affairs Health Care System

    Phoenix, Arizona

  • Vassar Brothers Medical Center

    Poughkeepsie, New York

  • South Texas Veterans Health Care System Audie L. Murphy Division

    San Antonio, Texas

  • CoxHealth

    Springfield, Missouri

  • Washington Health Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Canada9 sites
  • Rouge Valley Health System - Ajax and Pickering Site

    Ajax, Ontario

  • William Osler Health Centre - Brampton Civic Campus

    Brampton, Ontario

  • Foothills Medical Centre

    Calgary, Alberta

  • William Osler Health Centre - Etobicoke Campus

    Etobicoke, Ontario

  • St Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6

  • The Credit Valley Hospital

    Mississauga, Ontario

  • Pasqua Hospital

    Regina, Saskatchewan

  • Rouge Valley Health System - Centenary Site

    Scarborough Village, Ontario

  • St Paul's Hospital

    Vancouver, British Columbia

Other trials in Canada

About this study

Official title: A Multicenter, Cluster Randomized Trial of Enhanced Protein-Energy Provision Via the Enteral Route Feeding Protocol in Critically Ill Patients: The PEP uP Protocol

Critically ill patients are consistently underfed. Feeding protocols are standardized system tools used to guide nutrition practices, but to date have failed to improve delivery of nutrition. The PEP uP Protocol is a new enhanced feeding protocol. Twenty North American Intensive Care Units (ICUs) will assess baseline nutrition practices. Ten ICUs will be randomized to implement the PEP uP Protocol and educational intervention, and ten will be randomized to continue usual care. Nutrition practices will be reevaluated 6 months after baseline. The investigators hypothesize that the PEP uP Protocol will increase delivery of nutrition, and may ultimately lead to improved survival of critical illness.

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, innovative approach that protocolizes an aggressive set of strategies 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 a 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 fixed hourly rate goals to a new protocol 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.' Trophic feeds represent an idea to provide a low volume of a concentrated feeding solution for 24 hours or longer, designed to maintain gastrointestinal structure and function rather than meet their protein and caloric goals. This option should reduce the numbers of patients ordered to be kept nil per os (NPO). Thus, PEP uP patients may gain some of the benefit of early EN. 3) To optimize tolerance in the early phase of critical illness, we propose to use a semi elemental feeding solution instead of a standard polymeric solution. There is some evidence that these semi elemental solutions are better assimilated than polymeric solutions in the critical care setting. These solutions can be changed to a more traditional polymeric solution once the patient is tolerating adequate amounts of nutrition. 4) 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 and they are receiving all their protein requirements through their standard EN. This strategy guarantees that the patient will most likely receive all their protein requirements in the early phase of their critical illness. 5) Rather than wait for a problem with gastrointestinal tolerance to develop, 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. By preventing delayed gastric emptying, which frequently occurs in this patient population, we can improve nutritional adequacy. 6) Based on emerging evidence that a higher gastric residual volume (the volume of feeds remaining in the stomach when the bedside nurse aspirates the feeding tube) is safe and perhaps results in greater nutritional adequacy, we will include a higher gastric residual volume of 300ml in our protocol. 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.

Our hypothesis is that this aggressive feeding protocol combined with a nurse-directed nutrition educational intervention will be safe, acceptable, and effectively increase protein and energy delivery to critically ill patients. 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.

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) will be made available to all nurses, in bedside manuals and/or on the local intranet.

Study groups in NCT01167595
Study groupRoleWhat they receive
PEP uP ProtocolExperimentalPEP-uP protocol and treatment algorithm implemented for all patients in ICU.
Receives: Other: PEP uP Protocol
Standard Feeding ProtocolNo 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. Percentage of Prescribed Calories From Energy

    Total calories received from enteral nutrition/total prescription up to 12 evaluable ICU days

    Measured: first 12 days

  2. Percentage of Prescribed Protein

    Total protein received from enteral nutrition/total prescription up to 12 evaluable ICU days

    Measured: first 12 days

Secondary outcomes (3)
  1. Timeliness of Initiation of EN

    Time of the initiation of EN from ICU admit

    Measured: 60 days

  2. Percentage of Participants With Vomiting

    Measured: 60 days

  3. Percentage of Participants With Pneumonia

    Measured: 60 days

Timeline

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

  1. First posted22 Jul 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionNov 2011
  4. Study completionNov 2011

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,059 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01167595
Sponsor's protocol ID
PEPuP cRCT
Acronym
PEPuP
Status last verified
Apr 2021
First submitted
20 Jul 2010
Last updated
28 Apr 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
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
  • Heyland DK, Dhaliwal R, Lemieux M, Wang M, Day AG. Implementing the PEP uP Protocol in Critical Care Units in Canada: Results of a Multicenter, Quality Improvement Study. JPEN J Parenter Enteral Nutr. 2015 Aug;39(6):698-706. doi: 10.1177/0148607114531787. Epub 2014 Apr 18.

    PubMed 24748597

Questions about this trial

What is this clinical trial studying?

A study testing PEP uP Protocol in people with Critically Ill, run by Clinical Evaluation Research Unit at Kingston General Hospital at 18 sites in 2 countries.

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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, 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?

Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Prescribed Calories From Energy (time frame: first 12 days). The study lists 2 primary outcomes in all. 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 NCT01167595, which also lists 2 linked publications.

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 28 Apr 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in