Meeting Protein Targets in Critically Ill Patients

NCT03319836 | Completed

• 1 other identifier: 16.02.CA.HCN
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness; Dietary Modification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Daily caloric intake - Total Calories

  Daily up to 7 days of ICU stay

• Daily caloric intake - kcal/kg

  Daily up to 7 days of ICU stay

• Daily caloric intake from enteral nutrition

  Daily up to 7 days of ICU stay

• Percentage of prescribed calorie needs met

  Daily up to 7 days of ICU stay

• Feeding interruptions

  Daily up to 7 days of ICU stay

Study Arms (2)

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 \[2016\].

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8L 8E7, Canada

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

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

Study Officials

• Michele ApSimon

  Hamilton Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: October 24, 2017
• Study Start: October 4, 2017
• Primary Completion: February 16, 2018
• Study Completion: February 16, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)