The Effect of Higher Protein Dosing in Critically Ill Patients
- Conditions
- Critical IllnessMalnutrition
- Interventions
- Other: Higher Protein/Amino Acid GroupOther: Usual Protein/Amino Acid Group
- Registration Number
- NCT03160547
- Lead Sponsor
- Clinical Evaluation Research Unit at Kingston General Hospital
- Brief Summary
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.
- Detailed Description
The EFFORT Study is a multi-center, pragmatic, volunteer-driven, registry-based, randomized, clinical trial of 4000 nutritionally high-risk critically ill patients in the intensive care unit (ICU). We anticipate over 100 sites participating internationally, with each site enrolling a minimum of 30 patients. Patients will be randomized to 1 of 2 treatment groups: a usual prescription (≤1.2 g/kg/d) or a higher prescription (≥2.2 g/kg/d) of protein. Other than the protein amount the patient is randomized to the remainder of care provided to randomized patient will be at the discretion of ICU providers.
In both groups, targets will be achieved through any combination of enteral nutrition (high protein content in high group if available), protein supplements, and parenteral nutrition or amino acids only (as clinically available). The only difference between the 2 groups is the protein targets that are set. Similar efforts should be used in both groups to achieve at least 80% of these targets. The remainder of care provided to eligible patients will be at the discretion of ICU providers.
The investigator has posed two research questions:
Primary Research Question:
In critically ill patients with nutrition 'risk factors', what is the effect of prescribing a higher dose (≥2.2 grams/kg/day) of protein/amino acid administration compared to a usual dose prescribed ≤1.2 gram/kg/day on time to discharge alive from hospital?
Secondary Research Question:
In critically ill patients with nutrition 'risk factors', what is the effect of prescribing a higher dose (≥2.2 grams/kg/day) of protein/amino acid administration compared to patients prescribed ≤1.2 gram/kg/day on 60 day mortality?
The proposed hypothesis:
Compared to receiving usual dose of protein/amino acids, the administration of a higher dose of protein/amino acids (a consequence of having a higher prescription) to nutritionally high-risk critically ill patients will be associated with a quicker rate of recovery and an improved survival.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1329
-
≥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
- >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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Higher Protein/Amino Acid Group Higher Protein/Amino Acid Group Patients will receive a higher protein/amino acid dose (≥2.2 g/kg/d). Usual Protein/Amino Acid Group Usual Protein/Amino Acid Group Patients will receive a usual protein/amino acid dose (≤1.2 g/kg/d)
- Primary Outcome Measures
Name Time Method Time to discharge alive from hospital 60 day This is a composite of mortality and length of stay, evaluated up to 60 days post randomization
- Secondary Outcome Measures
Name Time Method 60-day mortality 60 day Mortality 60 days post randomization
Trial Locations
- Locations (83)
Virtua
🇺🇸Voorhees, New Jersey, United States
Burnaby Hospital
🇨🇦Burnaby, British Columbia, Canada
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Hospital of the University of Pennsylvania - MICU
🇺🇸Philadelphia, Pennsylvania, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Complejo Hospitalario Dr. Arnulfo Arias Madrid de la Caja de Seguro Social
🇵🇦Panamá, Panama
Aneurin bevan University Health Board
🇬🇧Newport, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Queen Alexandra
🇬🇧Portsmouth, United Kingdom
Royal Preston Hospital
🇬🇧Preston, United Kingdom
SwedishAmercian.Hospital
🇺🇸Rockford, Illinois, United States
Hospital Britanico de Buenos Aires
🇦🇷Buenos Aires, Argentina
University of Alberta
🇨🇦Edmonton, Alberta, Canada
NorthShore University HealthSystem
🇺🇸Evanston, Illinois, United States
MemorialCare Long Beach Medical Center
🇺🇸Long Beach, California, United States
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Legacy Salmon Creek Medical Center
🇺🇸Vancouver, Washington, United States
Sanatorio Allende
🇦🇷Cordoba, Argentina
Gold Coast Hospital and Health Service
🇦🇺Gold Coast, Australia
Casa de Saude Sao Jose
🇧🇷Rio de Janeiro, Brazil
Agioi Anargiroi Hospital
🇬🇷Athens, Greece
Hospital Icarai
🇧🇷Rio de Janeiro, Brazil
Hospital e Clinica Sao Goncalo
🇧🇷Rio de Janeiro, Brazil
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
London Health Sciences Center Hospital
🇨🇦London, Ontario, Canada
Abbotsford Regional Hospital
🇨🇦Abbotsford, British Columbia, Canada
Surrey Memorial Hospital
🇨🇦Surrey, British Columbia, Canada
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
Grey Bruce Health Services
🇨🇦Owen Sound, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
CIUSSS de l'Est-de-l'ile-de-Montreal- Installation Hospital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Apollo Hospitals Enterprises Limited
🇮🇳Mumbai, India
Evangelismos General Hospital
🇬🇷Athens, Greece
National Disaster Medical Center
🇯🇵Tokyo, Midori-cho, Tachikawa-shi, Japan
Emam Reza Hospital, Mashhad University of Medical Science
🇮🇷Mashhad, Iran, Islamic Republic of
Hospital Angeles Lomas
🇲🇽Mexico City, Estado De Mexico, Mexico
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Hospital General Dr. Manuel Gea Gonzalez
🇲🇽Mexico City, Cdmx, Mexico
University of Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital Irma De Lourdes Tzanetatos
🇵🇦Panamá, Panama
Hospital San Javier
🇲🇽Guadalajara, Jalisco, Mexico
Hospital Civil Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico
Hospital Regional Rafael Hernandez L. David Chiriqui Css
🇵🇦David, Chiriqui, Panama
King Faisal Specialist Hospital and Research Center
🇸🇦Riyadh, Saudi Arabia
University Southampton NHS Trust
🇬🇧Southampton, Hampshire, United Kingdom
Hospital Himas San Pablo Caguas
🇵🇷Caguas, Puerto Rico
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Royal Blackburn Hospital
🇬🇧Blackburn, United Kingdom
North Bristol NHS Trust
🇬🇧Bristol, United Kingdom
Northumbria Emergency Care Hospital
🇬🇧Cramlington, United Kingdom
St Richards Hospital
🇬🇧Chichester, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Medway Maritime Hospital
🇬🇧Gillingham, United Kingdom
Queen Elizabeth Hospital
🇬🇧London, United Kingdom
Northwick Park hospital
🇬🇧Harrow, United Kingdom
East Suffolk & North Essex Foundation Trust
🇬🇧Ipswich, United Kingdom
The Queen Elizabeth Hospital Kings Lynn NHS Trust
🇬🇧King's Lynn, United Kingdom
Royal Glamorgan Hospital
🇬🇧Llantrisant, United Kingdom
Colchester Hospital
🇬🇧London, United Kingdom
Kings College Hospital Denmark Hill
🇬🇧London, United Kingdom
Freeman Hospital
🇬🇧Newcastle, United Kingdom
University Hospital Lewisham
🇬🇧London, United Kingdom
Queen Elizabeth the Queen Mother Hospital
🇬🇧Margate, United Kingdom
The Tunbridge Wells Hospital
🇬🇧Pembury, United Kingdom
Lister Hospital East and North Hertfordshire Trust
🇬🇧Stevenage, United Kingdom
Royal Stoke Hospital
🇬🇧Stoke-on-Trent, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, United Kingdom
Torbay Hospital
🇬🇧Torquay, United Kingdom
Worthing Hospital
🇬🇧Worthing, United Kingdom
Yeovil District Hospital NHS Foundation Trust
🇬🇧Yeovil, United Kingdom
University of Tennessee Medical Center Knoxville
🇺🇸Knoxville, Tennessee, United States
Banner University Medical Center
🇺🇸Phoenix, Arizona, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Phoenix VA Health Care System
🇺🇸Phoenix, Arizona, United States
OU Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Froedtert Memorial Lutheran Hospital
🇺🇸Milwaukee, Wisconsin, United States
IU Health Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong