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Glutamine supplementation in burn patients: results of a randomized multicenter pilot study
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Veröffentlicht: | 9. Januar 2018 |
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Introduction: Glutamine may be of therapeutic value in treating burn injuries in order to reduce the various complications and organ dysfunctions during ICU stay. Until today, a small number of existing randomized trials of glutamine supplementation in burns patients have suggested a significant reduction in mortality, infection, and hospital length of stay. However, in other critically ill patient populations, there is a signal of increased mortality associated with glutamine administration. A trial of 2700 severe burn injury patients would be needed to rule out a mortality effect with glutamine supplementation. Prior to launching such a large initiative, we conducted a multicentre, randomized, pilot trial to assess the feasibility of the larger trial.
Methods: We conducted an international multicenter, double-blinded, randomized, pilot trial in 8 burn centers in Canada and the United States to demonstrate the feasibility of the trial protocol. We included patients with deep 2nd and/or 3rd degree burns at moderate or high risk for death. For patients 18–59 years old we required a TBSA (Total Burn Surface Area) ≥20%, or in the presence of an inhalation injury, a minimum of 15% TBSA was acceptable. For patients ≥60 years old we required a TBSA ≥10%. We excluded patients who were admitted more than 48 hours before screening and patients with advanced liver and kidney disease. Patients were randomized to receive glutamine through their feeding tube, every 4 hours for a total of 0.5 g/kg/day or maltodextrin (placebo) mixed with water. Study treatment (or placebo) continued until 7 days post last graft. Patients were followed for 6 months to document the development of organ dysfunctions, time to hospital discharge and survival.
Results: To date, we have recruited 203 patients from 8 sites. On average, participating sites enrolled 0.96 patients/site/month (range: 0.68 patients/month to 1.31 patients/month). There was good compliance with study procedures and >90% of prescribed doses of study medication were delivered. Only 2.0% of patients have been lost to follow-up at 6 months.
Conclusions: The RE-ENERGIZE study seems feasible. A larger, more definitive trial is warranted and currently recruiting in about 80 burn centers in different countries all over the world. Recently first European burn centers have succesfully started participating in this important randomized-controlled study.