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PEP uP Protocol in Surgical Patients

Primary Purpose

Critically Ill

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
PEP uP Protocol
Metoclopramide
Sponsored by
Clinical Evaluation Research Unit at Kingston General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critically Ill focused on measuring feeding protocol, enteral nutrition protocol, critically ill, surgical ICU, enteral nutrition, nutrition therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Jamaica Hospital Medical Center
  • Virginia Tech Carilion School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PEP uP Protocol

Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total Amount of Protein Received
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
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

Time to Initiation of Enteral Nutrition
Hours from intensive care unit (ICU) admission
ICU Length of Stay
Days in the intensive care unit
Mortality
Number of participants that died
Hospital Length of Stay
Days the participants were in the admitted in the hospital

Full Information

First Posted
May 27, 2015
Last Updated
October 5, 2020
Sponsor
Clinical Evaluation Research Unit at Kingston General Hospital
Collaborators
Nestle Health Science
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1. Study Identification

Unique Protocol Identification Number
NCT02459275
Brief Title
PEP uP Protocol in Surgical Patients
Official Title
PEP uP Protocol (Enhanced Protein-Energy Provision Via the Enteral roUte Feeding Protocol) in Surgical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Funding discontinued
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Evaluation Research Unit at Kingston General Hospital
Collaborators
Nestle Health Science

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
Keywords
feeding protocol, enteral nutrition protocol, critically ill, surgical ICU, enteral nutrition, nutrition therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEP uP Protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PEP uP Protocol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Other Intervention Name(s)
Reglan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Amount of Protein Received
Description
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.
Time Frame
12 days
Title
Total Amount of Energy
Description
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.
Time Frame
12 days
Secondary Outcome Measure Information:
Title
Time to Initiation of Enteral Nutrition
Description
Hours from intensive care unit (ICU) admission
Time Frame
12 days
Title
ICU Length of Stay
Description
Days in the intensive care unit
Time Frame
up to 60 days
Title
Mortality
Description
Number of participants that died
Time Frame
up to 60 days
Title
Hospital Length of Stay
Description
Days the participants were in the admitted in the hospital
Time Frame
up to 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daren K Heyland, MD
Organizational Affiliation
Clinical Evaluation Research Unit
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Jamaica Hospital Medical Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Facility Name
Virginia Tech Carilion School of Medicine
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20429886
Citation
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.
Results Reference
background
PubMed Identifier
23982032
Citation
Heyland DK, Murch L, Cahill N, McCall M, Muscedere J, Stelfox HT, Bray T, Tanguay T, Jiang X, Day AG. Enhanced protein-energy provision via the enteral route feeding protocol in critically ill patients: results of a cluster randomized trial. Crit Care Med. 2013 Dec;41(12):2743-53. doi: 10.1097/CCM.0b013e31829efef5.
Results Reference
background
PubMed Identifier
24748597
Citation
Heyland DK, Dhaliwal R, Lemieux M, Wang M, Day AG. Implementing the PEP uP Protocol in Critical Care Units in Canada: Results of a Multicenter, Quality Improvement Study. JPEN J Parenter Enteral Nutr. 2015 Aug;39(6):698-706. doi: 10.1177/0148607114531787. Epub 2014 Apr 18.
Results Reference
background
PubMed Identifier
24757062
Citation
McCall M, Cahill N, Murch L, Sinuff T, Bray T, Tanguay T, Heyland DK. Lessons Learned From Implementing a Novel Feeding Protocol: Results of a Multicenter Evaluation of Educational Strategies. Nutr Clin Pract. 2014 Aug;29(4):510-517. doi: 10.1177/0884533614531047. Epub 2014 Apr 22.
Results Reference
background
Links:
URL
http://www.criticalcarenutrition.com
Description
Critical Care Nutrition website including information on the PEP uP Protocol

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PEP uP Protocol in Surgical Patients

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