NCT01167595

Brief Summary

Critically ill patients are consistently underfed. Feeding protocols are standardized system tools used to guide nutrition practices, but to date have failed to improve delivery of nutrition. The PEP uP Protocol is a new enhanced feeding protocol. Twenty North American Intensive Care Units (ICUs) will assess baseline nutrition practices. Ten ICUs will be randomized to implement the PEP uP Protocol and educational intervention, and ten will be randomized to continue usual care. Nutrition practices will be reevaluated 6 months after baseline. The investigators hypothesize that the PEP uP Protocol will increase delivery of nutrition, and may ultimately lead to improved survival of critical illness.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,059

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
2 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
9.4 years until next milestone

Results Posted

Study results publicly available

April 6, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1.2 years

First QC Date

July 20, 2010

Results QC Date

September 21, 2020

Last Update Submit

April 6, 2021

Conditions

Critically Ill

Keywords

Critically illNutrition therapyEnteral nutrition

Outcome Measures

Primary Outcomes (2)

  • Percentage of Prescribed Calories From Energy

    Total calories received from enteral nutrition/total prescription up to 12 evaluable ICU days

    first 12 days

  • Percentage of Prescribed Protein

    Total protein received from enteral nutrition/total prescription up to 12 evaluable ICU days

    first 12 days

Secondary Outcomes (3)

  • Timeliness of Initiation of EN

    60 days

  • Percentage of Participants With Vomiting

    60 days

  • Percentage of Participants With Pneumonia

    60 days

Study Arms (2)

PEP uP Protocol

EXPERIMENTAL

PEP-uP protocol and treatment algorithm implemented for all patients in ICU.

Other: PEP uP Protocol

Standard Feeding Protocol

NO INTERVENTION

Enteral feeds are guided by a standard feeding protocol specified by pre-printed ICU admission orders. The admitting physician has the option of initiating the enteral feeding protocol or keeping the patient nil per os (NPO).

Interventions

PEP uP ProtocolOTHER

Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) will be made available to all nurses, in bedside manuals and/or on the local intranet.

PEP uP Protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Critically ill adults (i.e. \>18 years of age)
  • Mechanically ventilated before or within the first 6 hours of admission to ICU

You may not qualify if:

  • Nutrition (either EN or Parenteral Nutrition (PN)) started before admission to ICU
  • Not intubated within 6 hours of admission to ICU
  • Receiving non-invasive ventilation (i.e. mask ventilation) during the first 6 hours of ICU stay
  • Moribund (as evidenced by death within 48 hours of admission to ICU)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Phoenix Veterans Affairs Health Care System

Phoenix, Arizona, United States

Location

Medical Center of the Rockies

Loveland, Colorado, United States

Location

Washington Health Center

Washington D.C., District of Columbia, 20010, United States

Location

Henry Ford Macomb Hospital

Clinton Township, Michigan, United States

Location

CoxHealth

Springfield, Missouri, United States

Location

Lakes Region General Hospital

Laconia, New Hampshire, United States

Location

Nassau University Medical Center

East Meadow, New York, United States

Location

Vassar Brothers Medical Center

Poughkeepsie, New York, United States

Location

South Texas Veterans Health Care System Audie L. Murphy Division

San Antonio, Texas, United States

Location

Foothills Medical Centre

Calgary, Alberta, Canada

Location

St Paul's Hospital

Vancouver, British Columbia, Canada

Location

Rouge Valley Health System - Ajax and Pickering Site

Ajax, Ontario, Canada

Location

William Osler Health Centre - Brampton Civic Campus

Brampton, Ontario, Canada

Location

William Osler Health Centre - Etobicoke Campus

Etobicoke, Ontario, Canada

Location

St Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

The Credit Valley Hospital

Mississauga, Ontario, Canada

Location

Rouge Valley Health System - Centenary Site

Scarborough Village, Ontario, Canada

Location

Pasqua Hospital

Regina, Saskatchewan, Canada

Location

Related Publications (2)

  • 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.

    PMID: 20429886BACKGROUND

  • 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.

    PMID: 24748597RESULT

Related Links

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Sites struggled to embed the protocol in the initial admission order set and not able to achieve adequate dissemination of training materials. weekends or after hours, some patients admitted to the PEP uP sites did not actually receive the protocol.

Results Point of Contact

Title
Dr.Daren Heyland
Organization
CERU Queen's University
dkh2@queensu.ca
403-915-5573

Study Officials

  • Daren K Heyland, MD

    Clinical Evaluation Research Unit

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Daren Heyland

Study Record Dates

First Submitted

July 20, 2010

First Posted

July 22, 2010

Study Start

September 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

April 28, 2021

Results First Posted

April 6, 2021

Record last verified: 2021-04

Locations

US(9)CA(9)