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PEP uP Protocol in Surgical Patients

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Daniel D Yeh, MD, Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Daniel D Yeh, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02459275
First received: May 27, 2015
Last updated: March 16, 2017
Last verified: March 2017
  Purpose
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 Intervention
Critically Ill Other: PEP uP Protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Supportive Care
Official Title: PEP uP Protocol (Enhanced Protein-Energy Provision Via the Enteral roUte Feeding Protocol) in Surgical Patients

Further study details as provided by Daniel D Yeh, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Nutritional Adequacy (The total amount of energy or protein) [ Time Frame: 12 days ]
    The total amount of energy or 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.


Secondary Outcome Measures:
  • Protocol Feasibility (nursing questionnaire) [ Time Frame: 12 months ]
    Determined by a nursing questionnaire evaluating their opinion on the safety and acceptability of the protocol.

  • Time to initiation of enteral nutrition [ Time Frame: 12 days ]
  • ICU Length of stay [ Time Frame: 60 days ]
  • Mortality [ Time Frame: 60 days ]
  • Ventilator days [ Time Frame: 60 days ]
  • Hospital length of stay [ Time Frame: 60 days ]

Estimated Enrollment: 100
Study Start Date: July 2015
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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. A promotility agent will be started empirically concomitant with EN initiation. GRV will be checked every 4 hours and will be reinfused to the patient each time it is checked. GRV threshold is 500 ml. Once the patient shows tolerance of semi-elemental formula, the tube feeds will then be converted to standard polymeric formula. Daily, the patient will be reassessed for the need to continue promotility agents.
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. A promotility agent will be started empirically concomitant with EN initiation. GRV will be checked every 4 hours and will be reinfused to the patient each time it is checked. GRV threshold is 500 ml. Once the patient shows tolerance of semi-elemental formula, the tube feeds will then be converted to standard polymeric formula. Daily, the patient will be reassessed for the need to continue promotility agents.
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02459275

Contacts
Contact: Daniel D Yeh, MD 617-643-2439 dyeh2@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Daniel D Yeh, MD    617-643-2439    DYEH2@mgh.harvard.edu   
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Edward Kelly, MD       EKELLY1@PARTNERS.ORG   
United States, New York
Jamaica Hospital Medical Center Recruiting
Jamaica, New York, United States, 11418
Contact: Jeffrey Chan, MD    718-206-7110    jchan@jhmc.org   
Contact: Brian Young, RD       brian.young@sodexo.com   
United States, Virginia
Virginia Tech Carilion School of Medicine Recruiting
Roanoke, Virginia, United States, 24016
Contact: Brian Collier, MD    540-266-5971    brcollier@carilionclinic.org   
Sponsors and Collaborators
Clinical Evaluation Research Unit at Kingston General Hospital
Investigators
Study Director: Daren K Heyland, MD Clinical Evaluation Research Unit
  More Information

Additional Information:
Publications:
Responsible Party: Daniel D Yeh, MD, Daniel Dante Yeh, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02459275     History of Changes
Other Study ID Numbers: PEP uP Surgical RCT
Study First Received: May 27, 2015
Last Updated: March 16, 2017

Keywords provided by Daniel D Yeh, MD, Massachusetts General Hospital:
feeding protocol
enteral nutrition protocol
critically ill
surgical ICU
enteral nutrition
nutrition therapy

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 26, 2017