Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01102348
• Date of registration: 09/04/2010
• Prospective Registration: No
• Primary sponsor: Clinical Evaluation Research Unit at Kingston General Hospital
• Public title: Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients PEP-uP
• Scientific title: Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients: A Single Center Feasibility Trial of The PEP uP Protocol
• Date of first enrolment: May 2008
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01102348
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Daren K Heyland, MD
• Affiliation: Clinical Evaluation Research Unit

Key inclusion & exclusion criteria

Inclusion Criteria:

- Mechanically ventilated within 48 hours of admission to the intensive care unit

Exclusion Criteria:

- Less than 72 hours in intensive care unit before discharge



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Critically Ill

Intervention(s)

Other: PEP-uP Protocol

Primary Outcome(s)

Feasibility of the feeding protocol [Time Frame: 10-12 months]

Secondary Outcome(s)

Adequacy of EN [Time Frame: 10-12 months]

Episodes of pneumonia [Time Frame: 10-12 months]

Timeliness of initiation of EN [Time Frame: 10-12 months]

Episodes of aspiration [Time Frame: 10-12 months]

Episodes of vomiting [Time Frame: 10-12 months]

Secondary ID(s)

PEP-uP Pilot

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

FHS Foundation at Queen's Univeristy/Kingston General Hospital

Nestle Canada