Meeting Protein Targets in Critically Ill Patients (PROTARGET)

Meeting Protein Targets in Critically Ill Patients: A Retrospective Analysis

This is a retrospective study of protein and energy intake in enterally fed critically ill adult patients before and after the introduction of a very high protein enteral nutrition formula in a single center medical/surgical ICU.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Dietary Modification

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 8E7
      • Hamilton Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult medical/surgical ICU patients that received enteral nutrition with or without a very high protein enteral nutrition formula.

Description

Inclusion Criteria:

• Adult patients ≥ 18 years of age, mechanically ventilated
• Received enteral nutrition for a minimum of five days during the first week of ICU admission

Exclusion Criteria:

• Received parenteral nutrition during first week of ICU admission
• Acute renal failure not dialyzed
• Hepatic encephalopathy grade 3 or 4
• Intentional underfeeding/trophic feeding - including refeeding syndrome

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Pre-very high protein enteral nutrition; 20 enterally fed critically ill adult patients prior to the introduction of a very high protein enteral nutrition formula [2015].
Post-very high protein enteral nutrition; 20 enterally fed critically ill adult patients post the introduction of a very high protein enteral nutrition formula [2016].

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily total protein intake	Daily total protein intake and percent prescribed protein needs met during first week of ICU admission.	Daily up to 7 days of ICU stay

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily caloric intake - Total Calories	Total calories aggregate from all sources	Daily up to 7 days of ICU stay
Daily caloric intake - kcal/kg	Total volume consumed and weight will be used to measure kcal/kg	Daily up to 7 days of ICU stay
Daily caloric intake from enteral nutrition	Daily caloric intake from enteral nutrition, and medications (i.e. Propofol)	Daily up to 7 days of ICU stay
Percentage of prescribed calorie needs met	Percentage of prescribed calorie needs met	Daily up to 7 days of ICU stay
Feeding interruptions	Feeding interruptions; and reason for interruption, if recorded in electronic medical record/nursing flow sheets	Daily up to 7 days of ICU stay
Use of inotropes/vasopressors (highest daily dose prescribed)	Use of inotropes/vasopressors will be documented as a Yes/No.	Daily up to 7 days of ICU stay
Feeding tolerance	Feeding tolerance as recorded by clinicians in electronic medical record/nursing flow sheets [gastrointestinal side effects observed and documented: vomiting, elevated Gastric Residual Volumes (>200 mL), aspiration, pneumonia, diarrhea (Bristol stool chart definition and ≥ 3 liquid stools/day)]	Daily up to 7 days of ICU stay

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Collaborators: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Michele ApSimon, Hamilton Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2017
• Primary Completion (Actual): February 16, 2018
• Study Completion (Actual): February 16, 2018

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 16.02.CA.HCN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No