The Effect of Higher Protein Dosing in Critically Ill Patients

Not Applicable

Completed

• Conditions: Critical Illness; Malnutrition

• 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.

Study Timeline

• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-19
• Study Start: 2017-11-21
• Primary Completion: 2021-12-03
• Study Completion: 2021-12-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-25
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1329

Inclusion Criteria

1. ≥18 years old

2. Nutritionally 'high-risk' (meeting one of the below criteria)

   1. Low (≤25) or High BMI (≥35)
   2. 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.).
   3. Frailty (Clinical Frailty Scale 5 or more from proxy)
   4. Sarcopenia- (SARC-F score of 4 or more from proxy)
   5. From point of screening, projected duration of mechanical ventilation >4 days

3. Requiring mechanical ventilation with actual or expected total duration of mechanical ventilation >48 hours

Exclusion Criteria

1. >96 continuous hours of mechanical ventilation before screening
2. Expected death or withdrawal of life-sustaining treatments within 7 days from screening
3. Pregnant
4. The responsible clinician feels that the patient either needs low or high protein
5. 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

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)

Banner University Medical Center; 🇺🇸 Phoenix, Arizona, United States

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; 🇺🇸 Voorhees, New Jersey, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

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