Recovery after Critical Illness Critical Illness Muscle mass BetaHydroxy-Beta-Methylbutyrate(HMB) A randomized controlled trial
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged more than 20 2. On enteral feeding dose of more than 20 kcal per kg per day 3. Resolution or stabilization of the primary acute condition (e.g.,sepsis, ARDS, major surgery). o In a step-down setting (VDU, intermediate care in ICU, post ICU discharge to medical wards within 14 days) o Still in ICU but in the weaning phase of mechanical ventilation, characterized by: - Spontaneous breathing trials (SBTs) being conducted. - On low levels of ventilator support (e.g., pressure support less than 10 cmH2O above CPAP, CPAP less than 8 cmH2O). - FiO2 less than 0.4 - Hemodynamic stability: No or minimal vasopressor, inotropic support (e.g., norepinephrine less than 0.2 mcg per kg per min or equivalent doses of other vasopressors). - Not requiring deep sedation or neuromuscular blockade. - Prolonged mechanical ventilator more than 7 days - Clinical frailty scale 4-6 - NT 2-3 - Expected NG insertion more than 14 days 4. No contraindications to enteral feeding or feeding intolerance requiring intervention (i.e., prokinetic, NPO, TPN, or surgical intervention) 5. Expected to remain in hospital for more than 72 hours post - enrollment.
Exclusion criteria
Exclusion criteria: 1. Pre-existing muscle-wasting diseases (e.g., muscular dystrophy, advanced cancer, cachexia, patient who diagnosed with amyotrophic lateral sclerosis (ALS), myasthenia gravis, multiple sclerosis, or chronic inflammatory demyelinating polyneuropathy (CIDP).) 2. End-stage liver disease (Child-Pugh class C) 3. Terminal illness or palliative care focus 4. CKD that eGFR less than 30 or dialysis dependent (The nitrogen balance cannot be reliably calculated in patients with severe renal dysfunction because urinary urea excretion (UUN) is altered 5. Obesity (BMI more than 40) 6. Pregnancy or lactation 7. Absence of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of HMB EN feeding on muscle preservation in critically ill patients within 14-28 days 14 days Thigh muscle CSA and muscle thickness | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of HMB EN feeding on muscle preservation in critically ill patients within 14-28 days 14 days Thigh muscle CSA and muscle thickness,To assess the effects of HMB EN feeding 14 days and 28 days serum albumin and total protein levels,To determine the influence of HMB EN feeding End of study Length hospitalization,To observe the new onset End of study hospital-acquired infections | — |
Countries
Thailand
Contacts
Faculty of Medicine, Chiang Mai University