- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01167595
Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients (PEPuP)
A Multicenter, Cluster Randomized Trial of Enhanced Protein-Energy Provision Via the Enteral Route Feeding Protocol in Critically Ill Patients: The PEP uP Protocol
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada
- Foothills Medical Centre
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British Columbia
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Vancouver, British Columbia, Canada
- St Paul's Hospital
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Ontario
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Ajax, Ontario, Canada
- Rouge Valley Health System - Ajax and Pickering Site
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Brampton, Ontario, Canada
- William Osler Health Centre - Brampton Civic Campus
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Etobicoke, Ontario, Canada
- William Osler Health Centre - Etobicoke Campus
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Hamilton, Ontario, Canada, L8N 4A6
- St Joseph's Healthcare
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Mississauga, Ontario, Canada
- The Credit Valley Hospital
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Scarborough, Ontario, Canada
- Rouge Valley Health System - Centenary Site
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Saskatchewan
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Regina, Saskatchewan, Canada
- Pasqua Hospital
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Arizona
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Phoenix, Arizona, United States
- Phoenix Veterans Affairs Health Care System
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Colorado
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Loveland, Colorado, United States
- Medical Center of the Rockies
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Health Center
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Michigan
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Clinton Township, Michigan, United States
- Henry Ford Macomb Hospital
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Missouri
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Springfield, Missouri, United States
- CoxHealth
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New Hampshire
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Laconia, New Hampshire, United States
- Lakes Region General Hospital
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New York
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East Meadow, New York, United States
- Nassau University Medical Center
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Poughkeepsie, New York, United States
- Vassar Brothers Medical Center
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Texas
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San Antonio, Texas, United States
- South Texas Veterans Health Care System Audie L. Murphy Division
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Critically ill adults (i.e. >18 years of age)
- Mechanically ventilated before or within the first 6 hours of admission to ICU
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PEP uP Protocol
PEP-uP protocol and treatment algorithm implemented for all patients in ICU.
|
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.
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No Intervention: Standard Feeding Protocol
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Prescribed Calories From Energy
Time Frame: first 12 days
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Total calories received from enteral nutrition/total prescription up to 12 evaluable ICU days
|
first 12 days
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Percentage of Prescribed Protein
Time Frame: first 12 days
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Total protein received from enteral nutrition/total prescription up to 12 evaluable ICU days
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first 12 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timeliness of Initiation of EN
Time Frame: 60 days
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Time of the initiation of EN from ICU admit
|
60 days
|
Percentage of Participants With Vomiting
Time Frame: 60 days
|
60 days
|
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Percentage of Participants With Pneumonia
Time Frame: 60 days
|
60 days
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Collaborators and Investigators
Collaborators
Publications and helpful links
General 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEPuP cRCT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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