PEP uP Protocol in Surgical Patients



Status:Terminated
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/28/2018
Start Date:July 2015
End Date:September 2017

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PEP uP Protocol (Enhanced Protein-Energy Provision Via the Enteral roUte Feeding Protocol) in Surgical Patients

The main objective of this project is to asses for safety, feasibility and effectiveness of
an aggressive feeding protocol, PEP uP (Enhanced Protein-Energy Provision via the Enteral
Route Feeding Protocol) in increasing protein and energy delivery to critically ill surgical
patients. Our hypothesis is that an aggressive feeding protocol, PEP uP will be safe,
acceptable, and effectively increase protein and energy delivery to critically ill surgical
patients.

Gross underfeeding or iatrogenic malnutrition is prevalent in intensive care units throughout
the world. Critically ill patients only receive, on average, 40-50% of their prescribed
nutritional requirements. Inadequate provision of nutrition to these patients is associated
with increased complications, prolonged length of stay in the ICU and hospital, and increased
mortality. There are good data from large scale observational studies and randomized trials
that suggest better fed patients have better clinical and economic outcomes and there are
ICUs that consistently reach an average of 80-90% nutritional adequacy (amount of nutrition
received over amount prescribed) thus it appears to be a feasible goal.

The PEP uP protocol (Enhanced Protein-Energy Provision via the Enteral Route Feeding
Protocol) includes a new, innovative approach that protocolizes an aggressive set of
strategies to providing enteral nutrition (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 PEP uP 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.

2. Allowing "trophic feeds" a low volume of a concentrated feeding solution for 24 hours or
longer, designed to maintain gastrointestinal structure and function for those patients
who are deemed unsuitable for high volume intragastric feeds.

3. Prescribing semi-elemental feeding solution instead of a standard polymeric solution.

These can then be changed to more traditional polymeric solution once the patient is
tolerating adequate amounts of nutrition.

4. Prescribing protein supplements at initiation of EN and then discontinue if EN is well
tolerated and protein requirement are met through their standard EN.

5. Starting motility agents at the same time EN is started with a re-evaluation in the days
following to see if it is necessary.

This PEP uP protocol has been previously studied in two published studies enrolling primarily
medical patients. In the first study, a pilot before and after trial, the protocol seemed to
be feasible, safe, and acceptable to critical care nurses. No incidents compromising patient
safety were observed. (Heyland 2010) Rates of vomiting, regurgitation, aspiration, and
pneumonia were similar and the PEP uP group received significantly more energy and protein
(when they were prescribed to receive full volume as opposed to "trophic"). A subsequent
multi-center cluster randomized trial involving low-performing ICUs likewise demonstrated
that intervention sites had improvements in energy and protein delivery as well as a decrease
in average time from ICU admission to start of enteral nutrition compared to the control
group. (Heyland 2013).

Inclusion Criteria:

- Age ≥ 18 years

- ICU admission within past 48 hours

- Initiation of tube feeds currently planned by the surgical ICU (SICU) team and primary
surgical team

- Admitted by a surgical service to the SICU (not a medical ICU or neurology patient)

- Expected to remain mechanically ventilated for > 24 h and expected to require ICU care
for > 72 h after screening

Exclusion Criteria:

- Pregnancy

- Attending surgeon preference (they must agree to feeding their patient according to
the protocol in either arm using the goal rate determined by the SICU team and the
nutritionist)

- Contraindication to enteral nutrition (bowel obstruction, bowel discontinuity,
proximal enterocutaneous fistula, and short gut syndrome)

- Do not resuscitate (DNR) status or goals of care that specify limitations in medical
therapies

- Death expected within 24 hours
We found this trial at
4
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-2439
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Jamaica, New York 11418
Phone: 718-206-7110
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Roanoke, VA
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