Purpose: To evaluate the impact of alanyl-glutamine (Ala-Gln)-supplemented parenteral nutrition (PN) on clinical safety, nitrogen balance, intestinal permeability, and clinical outcome in postoperative patients.
Methods: One hundred twenty patients undergoing major abdominal surgery were enrolled. Protocol was approved and informed consent obtained. A double-blind protocol was designed as used in Europe. The clinical safety and outcome were observed for 60 patients in 2 centers (30 each). Sixty patients from 2 additional centers (30 each) were observed for clinical safety, nitrogen balance, intestinal permeability, and clinical outcome. All patients received isonitrogenous (0.20 g/kg body wt per day) and isocaloric (30 kcal/kg body wt per day) parenteral nutrition. The study group received Ala-Gln (Dipeptiven, Fresenius Kabi, Bad Homberg, Germany) 0.50 g/kg per day. Clinical chemistry variables, plasma amino acids profile, nitrogen balance, intestinal permeability (lactulose/mannitol ratio [L/M ratio]) were measured; hospital stay and infection rate were monitored. Statview was used for analysis of variance (ANOVA) or chi2 tests. Data were expressed as means +/- SD, and the significance level was p < .05.
Results: The patients in both groups were comparable prior to the operation. Vital signs and clinical chemical parameters were similar between groups. L/M ratio was 0.047+/-0.029 in control and 0.058+/-0.049 in study group before the operation (AOD-3). The L/M ratio was 0.132+/-0.081 in the control group, and 0.097+/-0.063 in study group on the seventh postoperative day. The difference of L/M ratio between groups was significant (p = .02). The cumulative nitrogen balance values were -5+/-162 mg/kg for 6 days in control and 144+/-145 mg/kg for 6 days in study group (p = .0004). All the patients recovered without incision infection. However, there were 3 cases that had infection-related complications in the control group; the difference was not significant between groups. The hospital stay in the study group was 12.5 days, which was 4 days less than that of the control group (p = .02).
Conclusions: Ala-Gln-supplemented PN was clinically safe, had better nitrogen balance, and maintained intestinal permeability in postoperative patients. The clinical outcome of the patients in study group was better; it was significantly different from the control group.