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PEP uP Protocol in Surgical Patients

NCT02459275 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-10-27

Study results available
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Summary

The main objective of this project is to asses for safety, feasibility and effectiveness of an aggressive feeding protocol, PEP uP (Enhanced Protein-Energy Provision via the Enteral Route Feeding Protocol) in increasing protein and energy delivery to critically ill surgical patients. Our hypothesis is that an aggressive feeding protocol, PEP uP will be safe, acceptable, and effectively increase protein and energy delivery to critically ill surgical patients.

Conditions

  • Critically Ill

Interventions

OTHER

PEP uP Protocol

Semi-elemental tube feeds are started at the hourly goal rate as determined by the 24 hour volume goal. Protein supplements will be started at the initiation of tube feeds to target a daily delivery of 2 g/kg/day.

DRUG

Metoclopramide

Metoclopramide 10mg Intravenous (IV) every 6 hours (q6h) or 5mg IV q6h for renal failure will be started empirically concomitant with EN initiation. Gastric Residual Volume (GRV) will be checked every 4 hours and will be reinfused to the patient each time it is checked.

Sponsors & Collaborators

  • Nestle Health Science

    collaborator INDUSTRY

  • Clinical Evaluation Research Unit at Kingston General Hospital

    lead OTHER

Principal Investigators

  • Daren K Heyland, MD · Clinical Evaluation Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-09-30
Completion
2017-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02459275 on ClinicalTrials.gov