Clinical trial NCT01167595: Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill
Keywords: Critically ill
Nutrition therapy
Enteral nutrition
Lead sponsor: Clinical Evaluation Research Unit at Kingston General Hospital
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
First posted: 2010-07-22
Enrollment: 1059
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Prescribed Calories From Energy
timeFrame: first 12 days
measure: Percentage of Prescribed Protein
timeFrame: first 12 days
Secondary outcomes:
measure: Timeliness of Initiation of EN
timeFrame: 60 days
measure: Percentage of Participants With Vomiting
timeFrame: 60 days
measure: Percentage of Participants With Pneumonia
timeFrame: 60 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Veterans Affairs Health Care System
state: Arizona
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Washington
country: United States
facility: Washington Health Center
state: District of Columbia
city: Clinton Township
country: United States
facility: Henry Ford Macomb Hospital
state: Michigan
city: Springfield
country: United States
facility: CoxHealth
state: Missouri
city: Laconia
country: United States
facility: Lakes Region General Hospital
state: New Hampshire
city: East Meadow
country: United States
facility: Nassau University Medical Center
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Medical Center
state: New York
city: San Antonio
country: United States
facility: South Texas Veterans Health Care System Audie L. Murphy Division
state: Texas
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
city: Ajax
country: Canada
facility: Rouge Valley Health System - Ajax and Pickering Site
state: Ontario
city: Brampton
country: Canada
facility: William Osler Health Centre - Brampton Civic Campus
state: Ontario
city: Etobicoke
country: Canada
facility: William Osler Health Centre - Etobicoke Campus
state: Ontario
city: Hamilton
country: Canada
facility: St Joseph's Healthcare
state: Ontario
city: Mississauga
country: Canada
facility: The Credit Valley Hospital
state: Ontario
city: Scarborough
country: Canada
facility: Rouge Valley Health System - Centenary Site
state: Ontario
city: Regina
country: Canada
facility: Pasqua Hospital
state: Saskatchewan
Study officials:
affiliation: Clinical Evaluation Research Unit
name: Daren K Heyland, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.