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PEP uP Protocol in Surgical Patients

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ClinicalTrials.gov Identifier: NCT02459275
Recruitment Status : Terminated (Funding discontinued)
First Posted : June 2, 2015
Results First Posted : October 27, 2020
Last Update Posted : October 27, 2020
Sponsor:
Collaborator:
Nestle Health Science
Information provided by (Responsible Party):
Daniel D Yeh, MD, University of Miami

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Critically Ill Other: PEP uP Protocol Drug: Metoclopramide Phase 4

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: PEP uP Protocol (Enhanced Protein-Energy Provision Via the Enteral roUte Feeding Protocol) in Surgical Patients
Study Start Date : July 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEP uP Protocol
Participants will receive the PEP uP protocol with the pro motility agent. The intervention will be provided until the tube feeds are stopped or patient is fed meals orally and will be tracked until hospital discharge or 60 days which ever occur first.
Other: PEP uP Protocol
Semi-elemental tube feeds are started at the hourly goal rate as determined by the 24 hour volume goal. Protein supplements will be started at the initiation of tube feeds to target a daily delivery of 2 g/kg/day.

Drug: Metoclopramide
Metoclopramide 10mg Intravenous (IV) every 6 hours (q6h) or 5mg IV q6h for renal failure will be started empirically concomitant with EN initiation. Gastric Residual Volume (GRV) will be checked every 4 hours and will be reinfused to the patient each time it is checked.
Other Name: Reglan

No Intervention: Standard of Care
Standard formula polymeric tube feeds started at a rate of 20 ml/hour. Gastric residual volume (GRV) will be checked every 4 hours. GRV is reinfused to the patient each time it is checked. GRV threshold is 200-500 ml. If the patient is tolerating tube feeds as determined by measuring the GRV, the rate is advanced by 20 ml/hour every 4 hours up to the goal rate. Participants will be followed until the tube feeds are stopped or patient is fed meals orally and will be tracked until hospital discharge or 60 days which ever occur first.



Primary Outcome Measures :
  1. Total Amount of Protein Received [ Time Frame: 12 days ]
    The total amount of protein received from either EN or parenteral nutrition (PN), inclusive of propofol, divided by the amount prescribed as per the baseline assessment and expressed as a percentage.

  2. Total Amount of Energy [ Time Frame: 12 days ]
    The total amount of energy received from either EN or parenteral nutrition (PN), inclusive of propofol, divided by the amount prescribed as per the baseline assessment and expressed as a percentage.


Secondary Outcome Measures :
  1. Time to Initiation of Enteral Nutrition [ Time Frame: 12 days ]
    Hours from intensive care unit (ICU) admission

  2. ICU Length of Stay [ Time Frame: up to 60 days ]
    Days in the intensive care unit

  3. Mortality [ Time Frame: up to 60 days ]
    Number of participants that died

  4. Hospital Length of Stay [ Time Frame: up to 60 days ]
    Days the participants were in the admitted in the hospital



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459275


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
Jamaica Hospital Medical Center
Jamaica, New York, United States, 11418
United States, Virginia
Virginia Tech Carilion School of Medicine
Roanoke, Virginia, United States, 24016
Sponsors and Collaborators
Clinical Evaluation Research Unit at Kingston General Hospital
Nestle Health Science
Investigators
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Study Director: Daren K Heyland, MD Clinical Evaluation Research Unit
  Study Documents (Full-Text)

Documents provided by Daniel D Yeh, MD, University of Miami:
Additional Information:
Publications:
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Responsible Party: Daniel D Yeh, MD, Daniel Dante Yeh, MD, University of Miami
ClinicalTrials.gov Identifier: NCT02459275    
Other Study ID Numbers: PEP uP Surgical RCT
First Posted: June 2, 2015    Key Record Dates
Results First Posted: October 27, 2020
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Daniel D Yeh, MD, University of Miami:
feeding protocol
enteral nutrition protocol
critically ill
surgical ICU
enteral nutrition
nutrition therapy
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action