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 |
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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) |
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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 |
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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 |