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. 2014 Dec 23;2014(12):CD007174. doi: 10.1002/14651858.CD007174.pub2

Coudray‐Lucas 2000.

Methods Design: randomised controlled trial. Multi‐centre or single‐centre: single‐centre. Period: not reported. Sample size calculation: based on previous study (De Bandt 1998). Generation of allocation: randomisation in blocks of 10, not clear how the blocks were generated. Allocation concealment: not reported. Blinded assessment of treatment allocation: The term 'double blinded' is used in the study, but it is unclear how it was applied. Investigators and participants were blind to product identity, although no further details were given.Withdrawals: 2 died of sepsis (1 from each group) and were excluded in week 1. Intention‐to‐treat analysis: not reported. Follow‐up: Until 95% of the wound healed, time was not reported
Participants How many enter the study on each arm? 49 participants, 2 died; therefore 47 included. n = 24 in treatment OKG group; 23 in control group
How many finish the study on each arm? all participants in both groups
Mean age: 37 years OKG; 34 years control
Mean total burn surface area (TBSA): 50% OKG; 48.4% control
Inclusion criteria: age 15 to 60 years, minimum TBSA 25%; on low flow rate continuous enteral nutrition
Exclusion criteria: admission after third postburn day, non‐thermal burn, severe associated trauma, hepatic or renal disease, pregnancy
Interventions All participants received polymeric diet aiming for 50 kcal/kg body weight and 0.4 g nitrogen/kg body weight, then were prospectively assigned to:
Experimental OKG group (n = 24): received 20 grams ornithine α‐ketoglutarate as 2 boluses of 10 g twice daily
Control (n = 23): received isonitrogenous control/soy protein mixture (Protil‐1; Jacquemaire)
Outcomes Mortality
Notes Wound healing, LOS on ICU, survival rate, duration of therapy
LOS not reported in Results section, days to 95% healing reported in a non‐reliable format for data extraction
Other outcomes (biochemical): serum transthyretin, plasma phenylalanine, urinary 3MH/Cr
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Unclear how blocks of 10 were generated
Allocation concealment (selection bias) Unclear risk Not clear whether the person who enrolled the participant was unaware of the allocation
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk The term "double blinded" is used in text, but it is unclear how this was applied. It is not stated for example whether labels were inserted on similar bags or vials
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 2 of 49 (4.08%) dropped out
2 died of sepsis (1 from each group) and were excluded in week 1
Other bias High risk 2 participants died early after randomisation and were not included