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Table 1 Ongoing studies currently recruiting adult patients (source: Clinicaltrials.gov – Jul 23, 2018)

From: High protein intake during the early phase of critical illness: yes or no?

NCT number Design Region Inclusion criteria Primary outcome Secondary outcomes Intervention Comparator Planned sample size
01833624 Open-label PRCT France • Traumatic brain injury
• Non-traumatic brain injury: stroke, intracranial and/or subarachnoid hemorrhage, subdural and/or extradural hematoma
• Expected duration of mechanical ventilation > 48 h
Nutritional efficacy Morbidity and mortality Small-peptide enteral feeding formula Whole-protein formula 206
02509520 PRCT USA • Age ≥ 45 years
• Respiratory insufficiency requiring mechanical ventilation
• ICU presentation < 6 days
• All four limbs intact and mobile
• Eligible for and able to participate in physical therapy
• Pre-admission Barthel Index > 70
-Muscle mass
-Global body strength
-Mobility status
-Short physical performance battery
-Time to weaning
-ICU/hospital length of stay
-Discharge disposition
-Weaning success
Functional strength and cardiopulmonary endurance training
MPR and high protein supplement goal of 1.6 g/kg/day protein
“No intervention”: MPR
“Active comparator”: MPR and high protein supplement
60
02106624 PRCT China • Need mechanical ventilation for more than 2 days
• Mean blood pressure more than 60 mmHg
• Predicted ICU stay more than 7 days
• Tolerance of parenteral or enteral nutrition
28-day and 90-day all cause mortality -Duration on ventilators
-ICU stay
-Infection incidence rate
-Liver function and renal function
-Diameter of midpoint of musculus rectus femoris
-Serum concentration of albumin, pre-albumin, retinaldehyde binding protein, transferrin
-Change of body composition
Nitrogen supply is as much as 2.5–3.0 g per kilogram (lean mass weight; EN/PN) 1.2–1.5 g per kilogram (lean mass weight; EN/PN) 80
02678325 PRCT Switzerland • Adult patients (age 18 years or older)
• Expected stay at the ICU of 4 days upon admittance or longer
• Expected enteral feeding during at least 4 days
-Amount of protein -Total amount of calories
-Nitrogen balance
-Gastric residual
-Number of diarrhea events
-Occurence of constipation as measured in time without defecation
High protein enteral nutrition formula (caloric density of 1.2 kcal/ml and protein percentage 33% of the total caloric intake) Standardized normal protein enteral nutrition formula (caloric density of 1.2 kcal/ml and protein 20% of the total caloric intake) 90
02865408 Open-label PRCT Canada • Mechanically ventilated adult patients (> 18 years old) admitted to ICU with an expected ICU dependency (alive and need for mechanical ventilation)
• Vasopressor therapy, or mechanical circulatory support, at the point of screening of an additional 3 days, as estimated by the treating physician
Whole body protein balance -Synthesis rates of hepatic secretory proteins
-Biomarker of amino acid restriction or repletion
-Metabolic substrates
-Resting energy expenditure
1.75 g/kg/day of protein (enteral supplemented with IV amino acids) 1.0 g/kg/day of protein (enteral) 30
03021902 Phase II RCT USA Requiring mechanical ventilation with actual or expected total duration of mechanical ventilation ≥ 48 h
Expected ICU stay ≥ 4 days after enrollment (to permit adequate exposure to the proposed intervention)
-Physical functioning -Overall strength-upper and lower extremity
-Quadriceps force-lower extremity strength
-Hand held dynamometry
-Distal strength-hand grip strength
-Overall physical functional status
-Mortality
-Length of ventilation
-ICU and hospital
-ICU readmission
-Re-intubation
-Hospital-acquired infections
-Discharge location (e.g., home vs rehab)
-Body composition (ultrasound)
-Health-related quality of life
-Physical functioning (Katz Index of Independence in Activities of Daily Living)
-Physical functioning (mental and cognitive functioning)
-Health care resource utilization
IV amino acid (2.0–2.5 g/kg/day) + in-bed cycle ergometry Usual care 142
03060668 Open-label PRCT Brazil •Critically ill patients
Mechanically ventilated
Expected length in the ICU > 3 days
Physical component of the SF-36 -Handgrip strength
-ICU and hospital mortality
Caloric intakes determined by indirect calorimetry + 2.0–2.2 g/kg/day of protein 25 kcal/kg/day and 1.4 to 1.5 g/kg/day of protein 294
03160547 Multi-center
pragmatic volunteer-driven
registry-based
randomized
Canada (over 100 international sites) Nutritional high-risk
Mechanical ventilation
60-day mortality -Nutritional adequacy
-Hospital mortality
-Readmission to ICU and hospital
-Duration of mechanical ventilation
-ICU length of stay
-Hospital length of stay
Higher prescription (≥ 2.2 g/kg/day) of protein (EN and/or PN) A lower prescription (≤ 1.2 g/kg/day) of protein (EN and/or PN) 4000
03170401 PRCT USA Trauma/surgery
Enteral nutrition expected ≥ 1 week
Serum transthyretin at 3 weeks after injury -Ventilator-free days
-Hospital-acquired pneumonia
Enteral protein supplementation Standard enteral formula 500
03231540 PRC Netherlands • Admitted to intensive care
• Mechanically ventilated
• Expected duration of ventilation of 72 h
• Expected to tolerate and require enteral nutrition for more than 72 h
• SOFA score > 6 on admission day
In vitro loss of skeletal muscle function -Loss of muscle function
-Medical research council sum score
-Changes in body composition (bioelectrical impedance analysis)
-Loss of muscle mass (ultrasound of the quadriceps femoris muscle and diaphragm, questionnaires)
-Quality of life
Whey protein supplement enriched enteral nutrition, with protein intake of 1.5 g/kg/day Standard enteral nutrition, with protein intake of 1 g/kg/day 50
03319836 Retrospective Canada ICU patients Daily total protein intake -Caloric intake
-Feeding interruptions ( tolerance)
-Use of inotropes (pressors)
Very high protein enteral nutrition Standard formula 40
  1. Abbreviations: PRCT prospective randomized controlled trial, ICU intensive care unit, MPR mobility-based physical rehab, EN enteral nutrition, PN parenteral nutrition, SOFA Sequential Organ Failure Assessment