None listed
Conditions
Brief summary
The study aims to establish whether the amino acid, glycine, is absorbed from the stomach in patients who are critically ill. It also aims to assess the effect of glycine supplementation on the structure and function of muscle. It is proposed that glycine will be absorbed from the stomach and cause an increase in glycine concentration in the blood. It is also thought that administering glycine to critically ill patients will have a protective effect on muscle, prevent muscle wasting and preserve physical function.
Interventions
Intervention 1: single test meal with supplemented glycine - performed after a 2 hour period without continuous feeding - group 1: 0.0667 g/kg glycine via enteral route (nasogastric tube) in 100ml standard enteral nutrition infused over 30 minutes - group 2: 0.1333 g/kg glycine via enteral route (nasogastric tube) in 100ml standard enteral nutrition, infused over 30 minutes - control: 100ml of standard enteral nutrition (without glycine supplementation), infused over 30 minutes - blood will be taken at baseline and thirty minutely for four hours Intervention 2: supplementation of standard enteral nutrition with glycine - Arm 1: 0.2g/kg/day glycine via enteral route (nasogastric tube) in sterile water, infused in two doses per day, each over 1 hour (in addition to standard care) - Arm 2: 0.4g/kg/day glycine via enteral route (nasogastric tube) in sterile water, infused in two doses per day, each over 1 hour (in addition to standard care) - Control: standard care (same volume and type of enteral formula without glycine supplementation) and the same volume of sterile water, infused in two doses, each over 1 hour -Duration: intervention will continue until the day of extubation or for a maximum of 7 days Procedures performed: 1. Quadricep muscle ultrasound to assess quadriceps muscle layer thickness (QMLT) - performed on days 0, 3 and 7 during intensive care unit (ICU) admission, at ICU discharge and 7 days after ICU discharge - performed by a trained practitioner (Drs Ali Abdelhamid, Bellomo or Deane) 2. Percutaneous muscle biopsy (50-150mg of tissue) from the quadriceps (vastus lateralis muscle) - performed under local anaesthetic and sterile technique - performed by a trained practitioner (Drs Ali Abdelhamid, Bellomo or Deane) - performed twice per patient [prior to the commencement of the intervention (day 0) and on the day of extubation (prior to extubation) or on day 7 of the intervention (whichever occurs earlier)] Timing: Intervention 1 will occur once informed consent is obtained and random allocation has occurred. Intervention 2 will begin on the same day, after intervention 1 has been completed. The decision maker may consent only to intervention 1, in which case the patient will be excluded from intervention 2.
Sponsors
Study design
Eligibility
Inclusion criteria
a. Aged 18 years or over b. Receiving invasive mechanical ventilation and expected to remain mechanically ventilated until the day after tomorrow c. Arterial or central venous line in situ d. Receiving or suitable to receive EN e. Expected to be receiving EN in the ICU until at least the day after tomorrow
Exclusion criteria
a. Death during ICU admission deemed to be inevitable b. Pregnancy c. Lower limbs amputated d. Spinal cord injury e. Presented with primary neuromuscular pathology f. Presented with disseminated cancer g. Bleeding diathesis (corrected INR > 1.5 and/or APTT > 50), or receiving anticoagulants beyond that required for venous thromboembolism prophylaxis or antiplatelet drugs other than aspirin h. Received > 72 hours of EN or PN during this ICU admission i. Intolerant of EN (gastric residual volume > 300mL) j. Already been admitted to ICU for > 96 hours during this hospitalization k. Previously enrolled in this study l. Requirement for specific nutritional therapy as determined by the treating doctor or dietitian