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Protein Consumption in Critically Ill Patients

Completed
Conditions
Dietary Modification
Critical Illness
Registration Number
NCT03048487
Lead Sponsor
Société des Produits Nestlé (SPN)
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2000
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Daily protein intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)Daily up to 7 days of ICU stay
Secondary Outcome Measures
NameTimeMethod
Destination for discharge (home, another acute care hospital, Long Term Acute Care, rehabilitation center, nursing home)Through study completion, assessed an estimated 36 months

Destination of Discharge will be assessed via chart review.

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 StayUp to 90 Days
Ventilator daysUp to 90 Days
Death during hospitalization (Yes/No)Through study completion, assessed an estimated 36 months
30 day readmissionIncidence up to 30 days post discharge
Percentage of daily caloric needs met (%) calorie needs met.Daily up to 7 days of ICU stay
Laboratory values (Alanine transaminase)Daily up to 7 days of ICU stay
Gastrointestinal side effects observed in enterally fed patients in the ICUDaily 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
Laboratory values (Aspartate aminotransferase)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 protein needs (descriptive name of scale)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
Antibiotic therapy daysUp to 90 Days
Enteral formula utilized (Standard, High protein, Very high protein)Daily up to 7 days of ICU stay
Percentage of daily protein needs met (%)Daily up to 7 days of ICU stay
Discharge against medical advice (Yes/No)Through study completion, assessed an estimated 36 months
Method for estimating caloric needs (descriptive name of scale) 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
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 (Glucose)Daily up to 7 days of ICU stay
Laboratory values (Ammonia)Daily up to 7 days of ICU stay
Insulin useDaily dose up to 7 days of ICU stay
Hospital Length of StayUp to 90 Days

Trial Locations

Locations (3)

Geisinger Wyoming Valley Medical Center

🇺🇸

Wilkes-Barre, Pennsylvania, United States

Geisinger Medical Center

🇺🇸

Danville, Pennsylvania, United States

Geisinger Community Medical Center, Scranton, PA

🇺🇸

Scranton, Pennsylvania, United States

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