Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients (PEP uP)

This study has been completed.
Sponsor:
Collaborator:
Nestle North America
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier:
NCT01167595
First received: July 20, 2010
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Critically Ill
Other: PEP uP Protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Multicenter, Cluster Randomized Trial of Enhanced Protein-Energy Provision Via the Enteral Route Feeding Protocol in Critically Ill Patients: The PEP uP Protocol

Further study details as provided by Clinical Evaluation Research Unit at Kingston General Hospital:

Primary Outcome Measures:
  • Adequacy of Enteral Nutrition (EN) [ Time Frame: 10-12 months ] [ Designated as safety issue: No ]
    Calculated as proportion of EN received versus EN prescribed


Secondary Outcome Measures:
  • Feasibility of the feeding protocol [ Time Frame: 10-12 months ] [ Designated as safety issue: Yes ]
    As judged by a nursing questionnaire that evaluates their opinion of its safety and acceptability

  • Episodes of vomiting [ Time Frame: 10-12 months ] [ Designated as safety issue: Yes ]
  • Timeliness of Initiation of Enteral Nutrition [ Time Frame: 10-12 months ] [ Designated as safety issue: No ]
  • Episodes of aspiration [ Time Frame: 10-12 months ] [ Designated as safety issue: Yes ]
  • Episodes of pneumonia [ Time Frame: 10-12 months ] [ Designated as safety issue: Yes ]

Enrollment: 1059
Study Start Date: September 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEP uP Protocol
PEP-uP protocol and treatment algorithm implemented for all patients in ICU.
Other: PEP uP Protocol
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.
No Intervention: Standard Feeding Protocol
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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  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: NCT01167595

Locations
United States, Arizona
Phoenix Veterans Affairs Health Care System
Phoenix, Arizona, United States
United States, Colorado
Medical Center of the Rockies
Loveland, Colorado, United States
United States, District of Columbia
Washington Health Center
Washington, District of Columbia, United States, 20010
United States, Michigan
Henry Ford Macomb Hospital
Clinton, Michigan, United States
United States, Missouri
CoxHealth
Springfield, Missouri, United States
United States, New Hampshire
Lakes Region General Hospital
Laconia, New Hampshire, United States
United States, New York
Nassau University Medical Center
East Meadow, New York, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, United States
United States, Texas
South Texas Veterans Health Care System Audie L. Murphy Division
San Antonio, Texas, United States
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada
Canada, British Columbia
St Paul's Hospital
Vancouver, British Columbia, Canada
Canada, Ontario
Rouge Valley Health System - Ajax and Pickering Site
Ajax, Ontario, Canada
William Osler Health Centre - Brampton Civic Campus
Brampton, Ontario, Canada
William Osler Health Centre - Etobicoke Campus
Etobicoke, Ontario, Canada
St Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
The Credit Valley Hospital
Mississauga, Ontario, Canada
Rouge Valley Health System - Centenary Site
Scarborough, Ontario, Canada
Canada, Saskatchewan
Pasqua Hospital
Regina, Saskatchewan, Canada
Sponsors and Collaborators
Clinical Evaluation Research Unit at Kingston General Hospital
Nestle North America
Investigators
Principal Investigator: Daren K Heyland, MD Clinical Evaluation Research Unit
  More Information

Additional Information:
Publications:
Responsible Party: Daren K. Heyland, Dr. Daren Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier: NCT01167595     History of Changes
Other Study ID Numbers: PEP uP cRCT
Study First Received: July 20, 2010
Last Updated: April 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Clinical Evaluation Research Unit at Kingston General Hospital:
Critically ill
Nutrition therapy
Enteral nutrition

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014