The Effect of Higher Protein Dosing in Critically Ill Patients

Completed · Not applicable

Conditions studied: Critical Illness, Malnutrition

In brief

The investigator will investigate the effects of higher protein/amino acid dosing (≥2.2 g/kg/d) vs usual protein/amino acid dosing (≤1.2 g/kg/d) on clinical outcomes in nutritionally high risk ill patients.

Key facts

Study ID

NCT03160547

Run by

Clinical Evaluation Research Unit at Kingston General Hospital

People needed

1329

Starts

2017-11-21

Expected to finish

2021-12-03

Last updated by the study team

2022-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years old
• Nutritionally 'high-risk' (meeting one of the below criteria)
• Low (≤25) or High BMI (≥35)
• Moderate to severe malnutrition (as defined by local assessments). We will document the means by which sites are making this determination and capture the elements of the assessment (history of weight loss, history of reduced oral intake, etc.).
• Frailty (Clinical Frailty Scale 5 or more from proxy)
• Sarcopenia- (SARC-F score of 4 or more from proxy)
• From point of screening, projected duration of mechanical ventilation >4 days
• Requiring mechanical ventilation with actual or expected total duration of mechanical ventilation >48 hours

You may not qualify if…

• >96 continuous hours of mechanical ventilation before screening
• Expected death or withdrawal of life-sustaining treatments within 7 days from screening
• Pregnant
• The responsible clinician feels that the patient either needs low or high protein
• Patient requires parenteral nutrition only and site does not have products to reach the high protein dose group.

Where it is running

• Phoenix VA Health Care System — Phoenix, Arizona, United States
• MemorialCare Long Beach Medical Center — Long Beach, California, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• SwedishAmercian.Hospital — Rockford, Illinois, United States
• IU Health Methodist Hospital — Indianapolis, Indiana, United States
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• Virtua — Marlton, New Jersey, United States
• Virtua — Mount Holly, New Jersey, United States
• Virtua — Voorhees Township, New Jersey, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Fairfield Medical Center — Lancaster, Ohio, United States
• OU Medical Center — Oklahoma City, Oklahoma, United States
• Hospital of the University of Pennsylvania - MICU — Philadelphia, Pennsylvania, United States
• University of Tennessee Medical Center Knoxville — Knoxville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Harborview Medical Center — Seattle, Washington, United States
• Legacy Salmon Creek Medical Center — Vancouver, Washington, United States
• Froedtert Memorial Lutheran Hospital — Milwaukee, Wisconsin, United States
• Hospital Britanico de Buenos Aires — Buenos Aires, Argentina
• Sanatorio Allende — Córdoba, Argentina
• Gold Coast Hospital and Health Service — Gold Coast, Australia
• Casa de Saude Sao Jose — Rio de Janeiro, Brazil
• Banner University Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.