- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04242966
The Effect of Higher Protein Dosing in Critically Ill Patients Ultrasound a Sub-study (EFFORTUS)
The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial: The EFFORT Ultrasound a Sub-study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The EFFORT Ultrasound (US) is a sub study of the parent EFFORT trial; a multi-center, pragmatic, volunteer-driven, registry-based, randomized, clinical trial of 4000 nutritionally high-risk critically ill patients in the intensive care unit. Patients will be randomized to 1 of 2 treatment groups: a usual care 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.
Patients in the US sub-study will undergo the US measures at baseline (within 24 hours of randomization, 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done. To ensure standardization and quality in the measures, we have created high quality training materials and will have US films sent centrally to abstract all measurements. In the first 10 patients enrolled in the US sub-study, participating sites will conduct a run-in phase where their submitted data will be evaluated for quality and reliability (both intra and inter-rater reliability) to ensure subsequent measures are of high quality. Nutritional and clinical data for these patients will be included in the parent EFFORT trial but the US measures may be omitted if quality is poor.
The investigator has posed the following research question:
Primary Sub Study 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 the usual care prescription (≤1.2 gram/kg/day) on muscle mass and quality, and 60 day mortality?
The proposed hypothesis:
Compared to receiving the usual care 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 greater muscle mass, improved survival and a quicker rate of recovery.
Study Type
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- - ≥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
Exclusion Criteria:
- >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 Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Usual Care
Patients will receive a usual protein/amino acid dose (≤1.2 g/kg/d)
|
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.
Patients will undergo the ultrasound measures at baseline (within 24 hours of randomization, day 10 days post randomization (if still in hospital) and just prior to hospital discharge.
In the event that hospital discharge is prior to day 10, the day 10 measure will not be done.
|
ACTIVE_COMPARATOR: Higher Protein/Amino Acid Group
Patients will receive a higher protein/amino acid dose (≥2.2 g/kg/d).
|
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.
Patients will undergo the ultrasound measures at baseline (within 24 hours of randomization, day 10 days post randomization (if still in hospital) and just prior to hospital discharge.
In the event that hospital discharge is prior to day 10, the day 10 measure will not be done.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Muscle mass of the quadriceps from baseline to day 10 post randomization
Time Frame: at baseline (within 24 hours of randomization, day 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done
|
Using ultrasound of quadriceps
|
at baseline (within 24 hours of randomization, day 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done
|
Change of Muscle quality of the quadriceps from baseline to day 10 post randomization
Time Frame: at baseline (within 24 hours of randomization, day 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done
|
Using ultrasound of quadriceps
|
at baseline (within 24 hours of randomization, day 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done
|
Collaborators and Investigators
Publications and helpful links
General Publications
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- Semler MW, Wanderer JP, Ehrenfeld JM, Stollings JL, Self WH, Siew ED, Wang L, Byrne DW, Shaw AD, Bernard GR, Rice TW; SALT Investigators * and the Pragmatic Critical Care Research Group; SALT Investigators. Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial. Am J Respir Crit Care Med. 2017 May 15;195(10):1362-1372. doi: 10.1164/rccm.201607-1345OC.
- Janz DR, Semler MW, Lentz RJ, Matthews DT, Assad TR, Norman BC, Keriwala RD, Ferrell BA, Noto MJ, Shaver CM, Richmond BW, Zinggeler Berg J, Rice TW; Facilitating EndotracheaL intubation by Laryngoscopy technique and apneic Oxygenation Within the ICU Investigators and the Pragmatic Critical Care Research Group. Randomized Trial of Video Laryngoscopy for Endotracheal Intubation of Critically Ill Adults. Crit Care Med. 2016 Nov;44(11):1980-1987. doi: 10.1097/CCM.0000000000001841.
- Semler MW, Janz DR, Lentz RJ, Matthews DT, Norman BC, Assad TR, Keriwala RD, Ferrell BA, Noto MJ, McKown AC, Kocurek EG, Warren MA, Huerta LE, Rice TW; FELLOW Investigators; Pragmatic Critical Care Research Group. Randomized Trial of Apneic Oxygenation during Endotracheal Intubation of the Critically Ill. Am J Respir Crit Care Med. 2016 Feb 1;193(3):273-80. doi: 10.1164/rccm.201507-1294OC.
- Canadian Critical Care Trials Group. A randomized trial of diagnostic techniques for ventilator-associated pneumonia. N Engl J Med. 2006 Dec 21;355(25):2619-30. doi: 10.1056/NEJMoa052904.
- Heyland D, Muscedere J, Wischmeyer PE, Cook D, Jones G, Albert M, Elke G, Berger MM, Day AG; Canadian Critical Care Trials Group. A randomized trial of glutamine and antioxidants in critically ill patients. N Engl J Med. 2013 Apr 18;368(16):1489-97. doi: 10.1056/NEJMoa1212722. Erratum In: N Engl J Med. 2013 May 9;368(19):1853. Dosage error in article text.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- The EFFORT Ultrasound
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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