Meeting Protein Targets in Critically Ill Patients

Critical Illness Clinical Trial

— PROTARGET  

Official title:

Meeting Protein Targets in Critically Ill Patients: A Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319836
• Other study ID #: 16.02.CA.HCN
• Status: Completed
• Start date: October 4, 2017
• Est. completion date: February 16, 2018

Study information

• Verified date: September 2018
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 16, 2018
• Est. primary completion date: February 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Dietary Modification

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Nestlé	Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Daily caloric intake - Total Calories	Total calories aggregate from all sources	Daily up to 7 days of ICU stay
Secondary	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
Secondary	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
Secondary	Percentage of prescribed calorie needs met	Percentage of prescribed calorie needs met	Daily up to 7 days of ICU stay
Secondary	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
Secondary	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
Secondary	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