Protein Consumption in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

Protein Consumption in Critically Ill Patients: A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048487
• Other study ID #: 16.11.CLI
• Status: Completed
• Start date: September 2016
• Est. completion date: September 2018

Study information

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

Clinical Trial Summary

A retrospective study of protein intake and needs as well as outcomes in critically ill adult patients. Data will be collected for up to 7 days of ICU stay.

Description:

This retrospective study of critically ill adults receiving enteral nutrition will assess the ability to meet estimated protein and energy needs via enteral nutrition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: September 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (age =18 years)

• Admitted to the ICU

• Administered at least one dose of enteral formula

Exclusion Criteria:

• Receiving exclusive oral or exclusive parenteral nutrition

Related Conditions & MeSH terms

• Critical Illness
• Dietary Modification

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Geisinger Community Medical Center, Scranton, PA	Scranton	Pennsylvania
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Nestlé	Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily protein intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)		Daily up to 7 days of ICU stay
Secondary	Enteral formula utilized (Standard, High protein, Very high protein)		Daily up to 7 days of ICU stay
Secondary	Daily caloric intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)		Daily up to 7 days of ICU stay
Secondary	Estimated caloric needs (Kcal/day)		Daily up to 7 days of ICU stay
Secondary	Method for estimating caloric needs (descriptive name of scale) calorie needs met.		Daily up to 7 days of ICU stay
Secondary	Percentage of daily caloric needs met (%) calorie needs met.		Daily up to 7 days of ICU stay
Secondary	Estimated protein needs (grams protein/day)		Daily up to 7 days of ICU stay
Secondary	Method for estimating protein needs (descriptive name of scale)		Daily up to 7 days of ICU stay
Secondary	Percentage of daily protein needs met (%)		Daily up to 7 days of ICU stay
Secondary	Laboratory values (Blood Urea Nitrogen)		Daily up to 7 days of ICU stay
Secondary	Laboratory values (Creatinine)		Daily up to 7 days of ICU stay
Secondary	Laboratory values (Aspartate aminotransferase)		Daily up to 7 days of ICU stay
Secondary	Laboratory values (Alanine transaminase)		Daily up to 7 days of ICU stay
Secondary	Laboratory values (Glucose)		Daily up to 7 days of ICU stay
Secondary	Laboratory values (Ammonia)		Daily up to 7 days of ICU stay
Secondary	Gastrointestinal side effects observed in enterally fed patients in the ICU		Daily up to 7 days of ICU stay
Secondary	Insulin use		Daily dose up to 7 days of ICU stay
Secondary	Health Outcomes (Renal failure, Seizures, Encephalopathy, Hyperglycemia, Hypoglycemia)		Daily up to 7 days of ICU stay
Secondary	Utilization of renal replacement therapy (Yes/No)		Daily up to 7 days of ICU stay
Secondary	Utilization of medications to manage hepatic encephalopathy (lactulose) (Yes/No)		Daily up to 7 days of ICU stay
Secondary	Neurocognitive status (Glasgow Coma Scale)		Daily up to 7 days of ICU stay
Secondary	Presence of delirium (Yes/No)		Daily up to 7 days of ICU stay
Secondary	ICU Length of Stay		Up to 90 Days
Secondary	Hospital Length of Stay		Up to 90 Days
Secondary	Ventilator days		Up to 90 Days
Secondary	Antibiotic therapy days		Up to 90 Days
Secondary	30 day readmission		Incidence up to 30 days post discharge
Secondary	Death during hospitalization (Yes/No)		Through study completion, assessed an estimated 36 months
Secondary	Destination for discharge (home, another acute care hospital, Long Term Acute Care, rehabilitation center, nursing home)	Destination of Discharge will be assessed via chart review.	Through study completion, assessed an estimated 36 months
Secondary	Discharge against medical advice (Yes/No)		Through study completion, assessed an estimated 36 months