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 |