Ornithine alpha-ketoglutarate improves wound healing in severe burn patients: A prospective randomized double-blind trial versus isonitrogenous controls

Objective: To compare the effectiveness on wound healing time in severe bur n patients of ornithine alpha-ketoglutarate supplementation of enteral feed ing vs, an isonitrogenous control. Previous clinical and experimental studi es suggest a beneficial effect of enterally administered ornithine alpha-ke toglutarate supplementation on protein metabolism in burn patients, but few data deal with clinical outcome, Design: Prospective double-blind randomized trial. Setting: Burn treatment center of an army hospital. Patients: Forty-seven severe burn patients with total burned body surface a reas of 25% to 95% and presence of full thickness burn who were prescribed early exclusive enteral nutrition. Either ornithine alpha-ketoglutarate or isonitrogenous control (soy protein mixture, Protil-1) were administered tw ice a day as a bolus (2 x 10 g) at 9 am and 9 pm for 3 wks. The patients we re evaluated for wound healing time (primary end point), antibiotic use, to lerance, duration of enteral nutrition, and nutritional status. Interventions: Serial blood samples were collected in each patient for dete rmination of serum transthyretin and plasma phenylalanine, and urine sampli ng was performed for determination of 3-methylhistidine excretion at day 4 and day 21 after burn injury. Measurements and Main Results: Wound healing times in patients receiving or nithine alpha-ketoglutarate or Protil-1 were 60 +/- 7 and 90 +/- 12 days, r espectively (p < .05) for similar grafted surfaces. Based on increased seru m transthyretin concentrations, both groups showed an improvement of nutrit ional status at day 21 after burn, Taking a cut-off value of 110 unit burn standard for severity of injury, plasma phenylalanine concentrations, and u rinary 3-methylhistidine/creatinine ratio were significantly reduced (p < . 05) in the less severe burn patients (<110 unit burn standard) supplemented with ornithine alpha-ketoglutarate. Conclusions: Ornithine alpha-ketoglutarate supplementation of enteral feedi ng significantly shortens wound healing time in severe burn patients. In ad dition, ornithine alpha-ketoglutarate administration was safe and well tole rated and decreased protein hypercatabolism in the less severe burn patient s.