CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,059 enrolled
Drug / intervention
PEP uP Protocolother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01167595
NCT01167595N/ACompleted
CompareCT.gov

A Multicenter, Cluster Randomized Trial of Enhanced Protein-Energy Provision Via the Enteral Route Feeding Protocol in Critically Ill Patients: The PEP uP Protocol

Clinical Evaluation Research Unit at Kingston General Hospital·interventional·Posted Jul 22, 2010·Updated Apr 28, 2021

In Brief

A clinical study evaluating PEP uP Protocol for Critically Ill. Completed, enrolled 1,059 participants across 18 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritically Ill
CountriesCanada, United States
CollaboratorsSociété des Produits Nestlé (SPN)

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 22, 2010
Enrollment StartSep 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.9 years ago

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.