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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03319836
Other study ID # 16.02.CA.HCN
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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