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Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients (PEP-uP)

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ClinicalTrials.gov Identifier: NCT01102348
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : April 14, 2010
Information provided by:

Study Description
Brief 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."

Condition or disease Intervention/treatment
Critically Ill Other: PEP-uP Protocol

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."

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients: A Single Center Feasibility Trial of The PEP uP Protocol
Study Start Date : May 2008
Primary Completion Date : April 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: PEP-uP Protocol (after)
PEP-uP protocol and treatment algorithm implemented for all patients in ICU.
Other: PEP-uP Protocol
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
No Intervention: Standard feeding protocol (before)
Enteral 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).

Outcome Measures

Primary Outcome Measures :
  1. Feasibility of the feeding protocol [ Time Frame: 10-12 months ]
    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.

Secondary Outcome Measures :
  1. Adequacy of EN [ Time Frame: 10-12 months ]
    Calculated as proportion of EN received versus EN prescribed

  2. Episodes of vomiting [ Time Frame: 10-12 months ]
  3. Timeliness of initiation of EN [ Time Frame: 10-12 months ]
  4. Episodes of aspiration [ Time Frame: 10-12 months ]
  5. Episodes of pneumonia [ Time Frame: 10-12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Less than 72 hours in intensive care unit before discharge
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102348

Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Clinical Evaluation Research Unit at Kingston General Hospital
FHS Foundation at Queen's Univeristy/Kingston General Hospital
Nestle Canada
Principal Investigator: Daren K Heyland, MD Clinical Evaluation Research Unit
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daren K Heyland, Clinical Evaluation Research Unit
ClinicalTrials.gov Identifier: NCT01102348     History of Changes
Other Study ID Numbers: PEP-uP Pilot
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: April 14, 2010
Last Verified: April 2010

Keywords provided by Clinical Evaluation Research Unit at Kingston General Hospital:
Critically Ill
Nutrition Therapy
Enteral Nutrition

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes