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

NCT01102348 | Completed

• 1 other identifier: PEP-uP Pilot
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to assess the feasibility, acceptability, and safety of a new feeding protocol, "The Enhanced Protein-Energy Provision via the Enteral Route in Critically Ill Patients: The PEP uP protocol."

Conditions

Critically Ill

Keywords

Critically Ill; Nutrition Therapy; Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

• Feasibility of the feeding protocol

  The primary outcome of this pilot study was the feasibility of the new feeding protocol as judged by a nursing questionnaire that evaluates their opinion of its safety and acceptability.

  10-12 months

Secondary Outcomes (5)

• Adequacy of EN

  10-12 months

• Episodes of vomiting

  10-12 months

• Timeliness of initiation of EN

  10-12 months

• Episodes of aspiration

  10-12 months

• Episodes of aspiration & pneumonia

  10-12 months

Study Arms (2)

PEP-uP Protocol (after)

EXPERIMENTAL

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

Other: PEP-uP Protocol

Standard feeding protocol (before)

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 Protocol OTHER

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) were made available to all nurses, in bedside manuals and on the local intranet

PEP-uP Protocol (after)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Less than 72 hours in intensive care unit before discharge

Sponsors & Collaborators

• Daren K. Heyland: lead
• Queen's University: collaborator
• Société des Produits Nestlé (SPN): collaborator

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (1)

• 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: 20429886 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daren K Heyland, MD

  Clinical Evaluation Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Clinical Evaluation Research Unit

Model Details: Before and after

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 13, 2010
• Study Start: June 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

CA (1)