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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

Tracking Information
First Submitted Date  ICMJE May 27, 2015
First Posted Date  ICMJE June 2, 2015
Results First Submitted Date  ICMJE October 5, 2020
Results First Posted Date  ICMJE October 27, 2020
Last Update Posted Date October 27, 2020
Study Start Date  ICMJE July 2015
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
  • Time to Initiation of Enteral Nutrition [ Time Frame: 12 days ]
    Hours from intensive care unit (ICU) admission
  • ICU Length of Stay [ Time Frame: up to 60 days ]
    Days in the intensive care unit
  • Mortality [ Time Frame: up to 60 days ]
    Number of participants that died
  • Hospital Length of Stay [ Time Frame: up to 60 days ]
    Days the participants were in the admitted in the hospital
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PEP uP Protocol in Surgical Patients
Official Title  ICMJE PEP uP Protocol (Enhanced Protein-Energy Provision Via the Enteral roUte Feeding Protocol) in Surgical Patients
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Critically Ill
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: PEP uP Protocol
    • Drug: Metoclopramide
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 24, 2018)
36
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2015)
100
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02459275
Other Study ID Numbers  ICMJE PEP uP Surgical RCT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daniel D Yeh, MD, University of Miami
Study Sponsor  ICMJE Clinical Evaluation Research Unit at Kingston General Hospital
Collaborators  ICMJE Nestle Health Science
Investigators  ICMJE
Study Director: Daren K Heyland, MD Clinical Evaluation Research Unit
PRS Account Clinical Evaluation Research Unit at Kingston General Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP