Critically IllPEP-uPNCT01102348
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 Daren K. Heyland at 1 site in Canada.
Trial 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." 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
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Mechanically ventilated within 48 hours of admission to the intensive care unit
Who cannot join
- Less than 72 hours in intensive care unit before discharge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients: A Single Center Feasibility Trial of The PEP uP Protocol
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."
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 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."
- 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) were made available to all nurses, in bedside manuals and on the local intranet
| Study group | Role | What they receive |
|---|---|---|
| PEP-uP Protocol (after) | Experimental | PEP-uP protocol and treatment algorithm implemented for all patients in ICU. Receives: Other: PEP-uP Protocol |
| Standard feeding protocol (before) | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10-12 months
Secondary outcomes (5)
Adequacy of EN
Calculated as proportion of EN received versus EN prescribed
Measured: 10-12 months
Episodes of vomiting
Safety endpoints
Measured: 10-12 months
Timeliness of initiation of EN
Actual timing of EN start
Measured: 10-12 months
Episodes of aspiration
Safety end points
Measured: 10-12 months
Episodes of aspiration & pneumonia
Safety end points
Measured: 10-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startJun 2008
- Primary completionMay 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Before and after
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daren K. Heyland
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Société des Produits Nestlé (SPN)
- Responsible party
- Sponsor-investigator, Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
- Investigators
- Daren K Heyland, MD, Principal investigator, Clinical Evaluation Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102348
- Sponsor's protocol ID
- PEP-uP Pilot
- Acronym
- PEP-uP
- Status last verified
- Dec 2020
- First submitted
- 9 Apr 2010
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients: A Single Center Feasibility Trial of The PEP uP Protocol
- ClinicalTrials.gov ID
- NCT01102348
- Acronym / sponsor ID
- PEP-uP / PEP-uP Pilot
- Conditions
- Critically Ill
- Keywords
- Critically Ill, Nutrition Therapy, Enteral Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Daren K. HeylandUniversity, hospital or other
- Collaborators
- Queen's University, Société des Produits Nestlé (SPN)
- Study start
- Jun 2008 (actual)
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before and after
| Arm | Type | Receives |
|---|---|---|
| PEP-uP Protocol (after) | Experimental | Other: PEP-uP ProtocolPEP-uP protocol and treatment algorithm implemented for all patients in ICU. |
| Standard feeding protocol (before) | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mechanically ventilated within 48 hours of admission to the intensive care unit
Key exclusion criteria (1 listed)
- Less than 72 hours in intensive care unit before discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP-uP ProtocolProtocol 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 | Other | PEP-uP Protocol (after) |
Primary outcome
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.
5 secondary outcomes
Adequacy of EN
Time frame: 10-12 months
Episodes of vomiting
Time frame: 10-12 months
Timeliness of initiation of EN
Time frame: 10-12 months
Episodes of aspiration
Time frame: 10-12 months
Episodes of aspiration & pneumonia
Time frame: 10-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Derived from this study: PubMed 20429886Heyland 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.
Related trials for Critically Ill
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daren K Heyland, MD principal investigator
Clinical Evaluation Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEP-uP Protocol in people with Critically Ill, run by Daren K. Heyland at 1 site in Canada.
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 1 inclusion and 1 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of the feeding protocol (time frame: 10-12 months). 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 NCT01102348, which also lists 1 linked publication.
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 17 Dec 2020.