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Protein Consumption in Critically Ill Patients

Protein Consumption in Critically Ill Patients: A Retrospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03048487
Enrollment
2000
Registered
2017-02-09
Start date
2016-09-30
Completion date
2018-09-30
Last updated
2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Dietary Modification

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.

Interventions

None listed

Sponsors

Geisinger Clinic
CollaboratorOTHER
Société des Produits Nestlé (SPN)
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Daily protein intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)Daily up to 7 days of ICU stay

Secondary

MeasureTime frameDescription
Ventilator daysUp to 90 Days
Antibiotic therapy daysUp to 90 Days
30 day readmissionIncidence up to 30 days post discharge
Death during hospitalization (Yes/No)Through study completion, assessed an estimated 36 months
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
Presence of delirium (Yes/No)Daily up to 7 days of ICU stay
ICU Length of StayUp to 90 Days
Enteral formula utilized (Standard, High protein, Very high protein)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
Hospital Length of StayUp to 90 Days
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 ICUDaily up to 7 days of ICU stay
Insulin useDaily 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
Destination for discharge (home, another acute care hospital, Long Term Acute Care, rehabilitation center, nursing home)Through study completion, assessed an estimated 36 monthsDestination of Discharge will be assessed via chart review.
Discharge against medical advice (Yes/No)Through study completion, assessed an estimated 36 months
Laboratory values (Blood Urea Nitrogen)Daily up to 7 days of ICU stay

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026