An interventional study of Usual Protein/Amino Acid Group and Higher Protein/Amino Acid Group in Critical Illness and Malnutrition, sponsored by Clinical Evaluation Research Unit at Kingston General Hospital. Completed at 86 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-28.
Sponsored by Clinical Evaluation Research Unit at Kingston General Hospital · Not applicable, Interventional, and Basic science
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.
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.
1,923 studies on the registry are indexed under Critical Illness; 465 are open to participants now.
This study's enrollment of 1,329 is above the median of 90 across 1,003 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Clinical Evaluation Research Unit at Kingston General Hospital is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Nutritionally 'high-risk' (meeting one of the below criteria)
Exclusion Criteria:
Patients will receive a usual protein/amino acid dose (≤1.2 g/kg/d)
Other: Usual Protein/Amino Acid Group
Patients will receive a higher protein/amino acid dose (≥2.2 g/kg/d).
Other: Higher Protein/Amino Acid Group
Protein targets will be set using pre-ICU dry actual weight. For patients with BMI \>30, ideal body weight based on a BMI of 25 will be used. We will endorse the guidelines for energy targets set forth by ASPEN/SCCM, especially as it pertains to the obese patient.
Protein targets will be set using pre-ICU dry actual weight. For patients with BMI \>30, ideal body weight based on a BMI of 25 will be used. We will endorse the guidelines for energy targets set forth by ASPEN/SCCM, especially as it pertains to the obese patient.
Time to discharge alive from hospital
This is a composite of mortality and length of stay, evaluated up to 60 days post randomization
Time frame: 60 day
60-day mortality
Mortality 60 days post randomization
Time frame: 60 day
Nutritional Adequacy
To be evaluated up to 60 days post randomization
Time frame: 60 day
Hospital mortality
To be evaluated up to 60 days post randomization
Time frame: 60 day
Readmission to ICU and Hospital
To be evaluated up to 60 days post randomization
Time frame: 60 day
Duration of Mechanical Ventilation
To be evaluated up to 60 days post randomization
Time frame: 60 day
ICU length of stay
To be evaluated up to 60 days post randomization
Time frame: 60 day
Hospital length of stay
To be evaluated up to 60 days post randomization
Time frame: 60 day
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Ran from Nov 2017 to primary completion in Dec 2021, 48 months.
Of 422 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's 48 months is above that.
Counting every sponsor, half of 427 studies reached it within 21 months; a quarter within 11 and three quarters within 37.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Clinical Evaluation Research Unit at Kingston General Hospital