Protein Consumption in Critically Ill Patients

Protein Consumption in Critically Ill Patients: A Retrospective Study

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.

Study Overview

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

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Scranton, Pennsylvania, United States, 18510
      • Geisinger Community Medical Center, Scranton, PA
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Wyoming Valley Medical Center

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

The study population will include all patients with an ICU admission receiving enteral nutrition in a 36-month period.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Daily protein intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)	Daily up to 7 days of ICU stay

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Collaborators: Geisinger Clinic
• Investigators: Principal Investigator: Joseph Layon, MD, FACP, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 2, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 16.11.CLI

Plan for Individual participant data (IPD)

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