Clinical trial NCT03048487: Protein Consumption in Critically Ill Patients
Official title: Protein Consumption in Critically Ill Patients: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Dietary Modification
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Geisinger Clinic
First posted: 2017-02-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily protein intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)
timeFrame: Daily up to 7 days of ICU stay
Secondary outcomes:
measure: Enteral formula utilized (Standard, High protein, Very high protein)
timeFrame: Daily up to 7 days of ICU stay
measure: Daily caloric intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)
timeFrame: Daily up to 7 days of ICU stay
measure: Estimated caloric needs (Kcal/day)
timeFrame: Daily up to 7 days of ICU stay
measure: Method for estimating caloric needs (descriptive name of scale) calorie needs met.
timeFrame: Daily up to 7 days of ICU stay
measure: Percentage of daily caloric needs met (%) calorie needs met.
timeFrame: Daily up to 7 days of ICU stay
measure: Estimated protein needs (grams protein/day)
timeFrame: Daily up to 7 days of ICU stay
measure: Method for estimating protein needs (descriptive name of scale)
timeFrame: Daily up to 7 days of ICU stay
measure: Percentage of daily protein needs met (%)
timeFrame: Daily up to 7 days of ICU stay
measure: Laboratory values (Blood Urea Nitrogen)
timeFrame: Daily up to 7 days of ICU stay
measure: Laboratory values (Creatinine)
timeFrame: Daily up to 7 days of ICU stay
measure: Laboratory values (Aspartate aminotransferase)
timeFrame: Daily up to 7 days of ICU stay
measure: Laboratory values (Alanine transaminase)
timeFrame: Daily up to 7 days of ICU stay
measure: Laboratory values (Glucose)
timeFrame: Daily up to 7 days of ICU stay
measure: Laboratory values (Ammonia)
timeFrame: Daily up to 7 days of ICU stay
measure: Gastrointestinal side effects observed in enterally fed patients in the ICU
timeFrame: Daily up to 7 days of ICU stay
measure: Insulin use
timeFrame: Daily dose up to 7 days of ICU stay
measure: Health Outcomes (Renal failure, Seizures, Encephalopathy, Hyperglycemia, Hypoglycemia)
timeFrame: Daily up to 7 days of ICU stay
measure: Utilization of renal replacement therapy (Yes/No)
timeFrame: Daily up to 7 days of ICU stay
measure: Utilization of medications to manage hepatic encephalopathy (lactulose) (Yes/No)
timeFrame: Daily up to 7 days of ICU stay
measure: Neurocognitive status (Glasgow Coma Scale)
timeFrame: Daily up to 7 days of ICU stay
measure: Presence of delirium (Yes/No)
timeFrame: Daily up to 7 days of ICU stay
measure: ICU Length of Stay
timeFrame: Up to 90 Days
measure: Hospital Length of Stay
timeFrame: Up to 90 Days
measure: Ventilator days
timeFrame: Up to 90 Days
measure: Antibiotic therapy days
timeFrame: Up to 90 Days
measure: 30 day readmission
timeFrame: Incidence up to 30 days post discharge
measure: Death during hospitalization (Yes/No)
timeFrame: Through study completion, assessed an estimated 36 months
measure: Destination for discharge (home, another acute care hospital, Long Term Acute Care, rehabilitation center, nursing home)
timeFrame: Through study completion, assessed an estimated 36 months
measure: Discharge against medical advice (Yes/No)
timeFrame: Through study completion, assessed an estimated 36 months
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Scranton
country: United States
facility: Geisinger Community Medical Center, Scranton, PA
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Joseph Layon, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References: