Safety and efficacy of a new peripheral intravenously administered amino acid solution containing glycerol and electrolytes.
A multicenter study was conducted to compare a new peripheral intravenously given solution containing 3 per cent amino acids, 3 per cent glycerol and a complete pattern of maintenance electrolytes--ProcalAmine--with an isonitrogenous amino acid control solution--FreAmine III--in patients undergoing elective gastrointestinal or vascular operations. Fifty-two patients received the control solution and 48 patients received the experimental solution in a double-blind, randomized trial for five consecutive postoperative days. A complete hematologic and biochemical assessment was carried out daily throughout the five day infusion period and two days after the termination of infusion. Nitrogen balance data were collected on each infusion day. Results indicate that the glycerol containing solution is safe and contributes to an improvement in nitrogen homeostasis on a daily and cumulative basis. The presence of ketosis was not related to an improvement in nitrogen balance. In conclusion, the addition of glycerol to dilute amino acid solutions is safe and improves nitrogen balance in the postoperative period. Additionally, use of the nonreducing sugar, glycerol, allows the manufacturer to sterilize amino acids and an energy substrate in a single unit. By precluding the need for admixing in the hospital pharmacy, risk of contamination may be reduced.
D000596:Amino Acids / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004573:Electrolytes / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005990:Glycerol / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009584:Nitrogen / Q000097:blood; D010288:Parenteral Nutrition; D010289:Parenteral Nutrition, Total; D011182:Postoperative Care; D011897:Random Allocation
D000596:Amino Acids; D004573:Electrolytes; D009584:Nitrogen; D005990:Glycerol