Comparative Assessment of Equivalence of the Post-Operative Use of Two Amino Acid Solutions

Objective: to compare the nutritional and metabolic effects of two amino acids-containing solutions, differed in amino acid profiles and sorbitol presence, when employed as a part of standardized combined post-operative nutritional support in patients undergoing surgery for abdominal cancer.

Materials and Methods. A prospective randomized study was conducted in two specialized hospitals. The study included 120 nutritionally stable patients aged 18–80 with stage I–III colorectal tumors and ASA class II–III anesthetic risk (mean BMI 25.3–27.6 kg/m²), who underwent elective abdominal surgeries and required parenteral administration of protein-carbohydrate nutrition solution (PCNS) for at least 5 days. Patients were randomly assigned into two groups for receiving PCNS formulations Amiparcenin or Aminoven formulated at 10-percent concentration (60 patients, each group). Both regimens involved administering an amino acid solution at 10 ml/kg/day in combination with a 10% dextrose solution at 10 ml/kg/day, alongside with early enteral feeding. The amino acid and nutritional profiles were assessed before initiation of nutritional support (T0), on the 2^nd (T1), and 5^th (T2) postoperative days. Key indicators included the sum of branched-chain amino acids (BCAA_sum), the sum of aromatic amino acids (AAA_sum), the ratio of BCAA/AAA, the integral indicator of amino acids in the urea cycle (UreaCycle_sum), and index ratios of ornithine to citrulline, arginine to ornithine, and arginine to citrulline. Additionally, total protein, albumin, nitrogen balance, bioimpedance indicator of active cellular mass (BIA ACM), creatinine, liver function markers, and electrolyte profiles were analyzed. To evaluate clinical equivalence, a two one-sided tests (TOST) analysis was employed with pre-defined limits of clinically acceptable difference (∆) for each parameter.

Results. By day 5, both groups showed statistically significant changes in total protein and albumin levels, reflecting the transition from the early catabolic phase and the impact of nutritional support; no intergroup differences were observed for these parameters, and the TOST analysis confirmed their equivalence within the predefined limits of ∆. The branched-chain amino acids (BCAA_sum) level increased from T0 to T1 and then stabilized at T2 in both groups; the factors «group» and the «group×period» interaction were not significant (p = 0.285 and p = 0.362, respectively), however, the equivalence of absolute BCAA_sum values at T2 with a narrow ∆ = 10 µmol/L was not confirmed (p-TOST> 0.05). For AAA_sum, differences were documented based on the «group» factor (p = 0.035) and the interaction «period×group» (p = 0.0099), with alignment of absolute values at T2. The ratio of BCAA/AAA and the index indicators of the urea cycle (Orn/Cit, Arg/Orn, Arg/Cit) remained stable, with no intergroup differences, and met the equivalence criteria throughout all observation periods. According to bio-impedance analysis, the Amiparcenin group showed a more significant increase in active cell mass (p by Friedman = 0.00001; intergroup p at T1 = 0.0048, at T2 = 0.00014), while the Aminoven group did not show significant dynamics; moreover, the TOST analysis with a wide ∆ showed formal equivalence in BIA ACM. Creatinine, urea, transaminases, and electrolyte levels remained comparable between the groups and were within clinically acceptable ranges; equivalence for these parameters was confirmed.

Conclusion. In the early postoperative period, Amiparcenin and Aminoven 10% solutions provide comparable amino acid and nutritional supply, and biochemical effects as a part of standardized combined nutritional support in patients with abdominal cancers. The studied regimens met equivalence criteria for most essential amino acid indicators (including BCAA/AAA), markers of inflammation, protein metabolism, liver and kidney function, and electrolyte balance. The differences found in absolute values of BCAA_sum, AAA_sum, UreaCycle_sum, and malondialdehyde (MDA) do not translate into clinically significant shifts during the first 5 days post-surgery.

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