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

Primary Purpose

Critically Ill

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PEP-uP Protocol
Sponsored by
Daren K. Heyland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critically Ill focused on measuring Critically Ill, Nutrition Therapy, Enteral Nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kingston General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PEP-uP Protocol (after)

Standard feeding protocol (before)

Arm Description

PEP-uP protocol and treatment algorithm implemented for all patients in ICU.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adequacy of EN
Calculated as proportion of EN received versus EN prescribed
Episodes of vomiting
Safety endpoints
Timeliness of initiation of EN
Actual timing of EN start
Episodes of aspiration
Safety end points
Episodes of aspiration & pneumonia
Safety end points

Full Information

First Posted
April 9, 2010
Last Updated
December 15, 2020
Sponsor
Daren K. Heyland
Collaborators
Queen's University, Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT01102348
Brief Title
Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients
Acronym
PEP-uP
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 Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 2008 (Actual)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daren K. Heyland
Collaborators
Queen's University, Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. 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."
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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
Keywords
Critically Ill, Nutrition Therapy, Enteral Nutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Before and after
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEP-uP Protocol (after)
Arm Type
Experimental
Arm Description
PEP-uP protocol and treatment algorithm implemented for all patients in ICU.
Arm Title
Standard feeding protocol (before)
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
PEP-uP Protocol
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility of the feeding protocol
Description
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.
Time Frame
10-12 months
Secondary Outcome Measure Information:
Title
Adequacy of EN
Description
Calculated as proportion of EN received versus EN prescribed
Time Frame
10-12 months
Title
Episodes of vomiting
Description
Safety endpoints
Time Frame
10-12 months
Title
Timeliness of initiation of EN
Description
Actual timing of EN start
Time Frame
10-12 months
Title
Episodes of aspiration
Description
Safety end points
Time Frame
10-12 months
Title
Episodes of aspiration & pneumonia
Description
Safety end points
Time Frame
10-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daren K Heyland, MD
Organizational Affiliation
Clinical Evaluation Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20429886
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.
Results Reference
derived

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

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